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f6c64bb3-1836-4685-8541-8856f003524b
No concurrent CYP3A4 inhibitors or inducers Patients with non-measurable diseases are only eligible for phase I of the primary trial.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Title: Placebo + Letrozole 2.5 mg secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Overall Number of Participants Analyzed: 108 secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Title: Gemcitabine Plus Docetaxel the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Treatment continues until progression of disease at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Overall Number of Participants Analyzed: 239 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Unit of Measure: months 9.28 (7.73 to 10.79) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Title: Docetaxel Plus Capecitabine the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins. the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Overall Number of Participants Analyzed: 236 the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Median (95% Confidence Interval) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Measure Type: Count of Participants secondary trial: Unit of Measure: months 8.88 (7.37 to 11.05) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1
79272218-91b9-4331-ba44-6a3709a13f62
primary trial: Unit of Measure: Participants 89 82.4% secondary trial: Time to Disease Progression (Initial Treatment) the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.
1