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dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Cardiac failure congestive 1/752 (0.13%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Left ventricular dysfunction 0/752 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Total: 117/382 (30.63%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Anaemia 3/382 (0.79%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Disseminated intravascular coagulation 0/382 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Febrile neutropenia 11/382 (2.88%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Neutropenia 20/382 (5.24%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Thrombocytopenia 0/382 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Atrial fibrillation 1/382 (0.26%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Atrial flutter 1/382 (0.26%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Cardiac failure congestive 0/382 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
dbed5471-c2fc-45b5-b26f-430c9fa37a37 | primary trial: Confusional state 1/32 (3.13%) secondary trial: Left ventricular dysfunction 1/382 (0.26%) Heart-related adverse events were recorded in both the primary trial and the secondary trial. | 1 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with histologic confirmation of invasive breast carcinoma. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients must have intact primary tumor. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients greater than or equal to 18 years. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients should have T1N1-3M0 or T2-4 N0-3M0. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with bilateral breast cancer are eligible. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with second primary breast cancers are eligible. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients should have a Karnofsky performance scale of greater than or equal to 70%. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients must have clinically measurable disease to be treated in the neoadjuvant setting. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of greater than or equal to 1500/mm^3, and platelet count greater than or equal to 100000mm^3. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients should have adequate renal function with creatinine levels within normal range. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients should have a normal left ventricular ejection fraction (LVEF) of greater than or equal to 50%. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP). Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | WOCBP must use a reliable and appropriate contraceptive method during the study and six months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients must agree to have study biopsies. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Her2Neu, ER and PR positive patients should be excluded. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with Inflammatory breast cancer (IBC) are excluded. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with an organ allograft or other history of immune compromise. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Prior treatment with any investigational drug within the preceding 4 weeks. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Chronic treatment with systemic steroids or another immunosuppressive agent. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | A Known history of HIV seropositivity. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day). Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Other concurrent and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration). Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
20c35c89-8d23-4be3-b603-ac0ee0f3b4de | Patients with a pre-existing peripheral neuropathy. Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Laser Therapy Alone secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Laser Therapy Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Laser Therapy Alone secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Laser Therapy Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Laser Therapy Alone secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered laser treatment secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered laser treatment secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered laser treatment secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered laser treatment secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered laser treatment secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: laser: therapist administered laser secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: laser: therapist administered laser secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: laser: therapist administered laser secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: laser: therapist administered laser secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: laser: therapist administered laser secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Mld Alone secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Mld Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Mld Alone secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Mld Alone secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: Mld Alone secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered manual lymphatic drainage secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered manual lymphatic drainage secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered manual lymphatic drainage secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered manual lymphatic drainage secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: therapist administered manual lymphatic drainage secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Part A Abemaciclib: HR+, HER2+ Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Part B Abemaciclib: HR+, HER2- Breast Cancer Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
f17cb242-419d-4f5d-bfa4-41494ed5ac0e | primary trial: manual lymphatic drainage: therapist administered massage therapy secondary trial: Participants may continue to receive treatment until discontinuation criteria are met. Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: The patient must be 18 years or older. Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Core biopsy should definitively demonstrate invasive carcinoma. Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Invasive carcinoma should be ER-apha receptor positive Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible. Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Patients in whom surgical excision of the tumor is part of standard of care management Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: ECOG score of 0 or 1 Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery) Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Consent to participate in DBBR (RPCI only) Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Male patients are not eligible for this study Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan. Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Patients with diagnosis by FNA cytology only Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Pregnant or lactating women Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Psychiatric or addictive disorders that would preclude obtaining informed consent Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Women with non-invasive disease or microinvasion are not eligible. Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Women undergoing neoadjuvant chemotherapy are not eligible Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: women currently on tamoxifen and raloxifene for prevention are not eligible Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh. Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
fc5c4554-7ce9-4c16-b374-a3cd9d15b021 | primary trial: Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study secondary trial: Patients with a known mutation in p53 (Li Fraumeni Syndrome) Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Diagnosis may be made by fine needle aspiration cytology or core biopsy Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible* Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Locally advanced disease includes any of the following: Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Primary tumor 5 cm (T3) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Tumor of any size with direct extension to the chest wall or skin (T4a-c) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Inflammatory breast cancer (T4d) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |
96b77cdd-aa9f-4770-8447-8a04d9ca5da7 | Fixed axillary lymph node metastases (N2) Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | 0 |