Ids
stringlengths 36
36
| text
stringlengths 45
2.03k
| label
int64 0
1
|
|---|---|---|
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Time frame: 6 months secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795) secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Akt Inhibitor GSK2141795: Given PO secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Laboratory Biomarker Analysis: Correlative studies secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Time frame: Week 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Arm/Group Title: Trastuzumab the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Overall Number of Participants Analyzed: 26 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Unit of Measure: percentage of participants 54.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Arm/Group Title: Lapatinib the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Overall Number of Participants Analyzed: 29 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Measure Type: Number the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |
97e3b0d7-3320-4eb5-bc42-5031db87692e | primary trial: Trametinib: Given PO secondary trial: Unit of Measure: percentage of participants 45.0 the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients. | 0 |