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e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Epistaxis 1/7 (14.29%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Epistaxis 1/7 (14.29%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Epistaxis 1/7 (14.29%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Epistaxis 1/7 (14.29%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Interstitial lung disease 1/7 (14.29%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Interstitial lung disease 1/7 (14.29%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Interstitial lung disease 1/7 (14.29%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Interstitial lung disease 1/7 (14.29%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Interstitial lung disease 1/7 (14.29%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Pleural effusion 2/7 (28.57%) secondary trial: Total: 8/101 (7.92%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Pleural effusion 2/7 (28.57%) secondary trial: Vertigo * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Pleural effusion 2/7 (28.57%) secondary trial: Infected lymphocele * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Pleural effusion 2/7 (28.57%) secondary trial: Ejection fraction decreased * 5/101 (4.95%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a | primary trial: Pleural effusion 2/7 (28.57%) secondary trial: Lymphoedema * 1/101 (0.99%) The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%). | 1 |
97812fde-57f3-4299-be34-dd436757adde | The patient must consent to participate in the study and must have signed an approved consent form conforming with federal and institutional guidelines. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | The patient must have a life expectancy of at least 10 years and a Zubrod performance status of 0 or 1. (Comorbid conditions but not the diagnosis of breast cancer should be taken into consideration when determining life expectancy.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | The interval between the last surgery for breast cancer staging or treatment and randomization must be no more than 84 days. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | The tumor must be invasive carcinoma of the breast on histologic examination. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | All of the following staging criteria must be met: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | By clinical and pathologic evaluation, primary tumor must be T1-3; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | By clinical evaluation, ipsilateral nodes must be cN0, cN1, or cN2a; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | By pathologic evaluation, ipsilateral nodes must be pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b (only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection and with more than 3 positive axillary lymph nodes). Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitely negative] will be considered positive regardless of the methodology used.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients must have had either a lumpectomy or a total mastectomy. Patients must have completed one of the following procedures for evaluation of pathologic nodal status. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes (This approach is strongly recommended.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Sentinel lymphadenectomy alone if one of the following criteria is met: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Surgeon elects not to remove additional non-sentinel nodes (This approach is strongly discouraged, but will not preclude participation in B-38.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Axillary lymphadenectomy without sentinel node isolation procedure. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients must have no clinical or radiologic evidence of metastatic disease. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease. Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients with aspartate transaminase (AST) or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging fails to demonstrate metastatic disease and the following requirements are met at the time of randomization. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Postoperative absolute granulocyte count (AGC) must be greater than or equal to 1200/mm3. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Postoperative platelet count must be greater than or equal to 100,000/mm3. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | The following criteria for postoperative evidence of adequate hepatic function must be met: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | the AST must be less than or equal to 1.5 x ULN for the lab; and Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | alkaline phosphatase and AST cannot both be greater than ULN. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Postoperative serum creatinine must be less than or equal to ULN. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | At the time of randomization, the patient must have had the following: history and physical exam, EKG, and imaging of the chest within the past 3 months and bilateral mammogram within the past 6 months. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF), measured by Multiple Gated Acquisition (MUGA) scan or echocardiogram, greater than or equal to lower limit of normal (LLN) for the facility performing the procedure and no evidence of regional wall abnormalities. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Special conditions for eligibility of lumpectomy patients: radiation therapy and surgery. Patients treated by lumpectomy must meet all the eligibility criteria in addition to the following: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible if eligibility criteria for lumpectomy are met. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients for whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary evaluation has been completed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Irradiation of regional lymph nodes is optional, but plans for radiation therapy must be declared by the investigator prior to randomization for stratification purposes. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Special conditions for eligibility of mastectomy patients: radiation therapy o Postmastectomy chest wall and/or regional nodal irradiation is optional. Plans for radiation in mastectomy patients must be declared by the investigator prior to randomization for stratification purposes. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Ineligibility Criteria Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Male patients are not eligible for this study. Women with one or more of the following conditions or prior therapies are also ineligible for this study: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Tumor that has been determined to be human epidermal growth factor receptor 2 (HER2)-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification). Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Contralateral breast cancer (invasive or DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Primary tumor staged as T4 for any reason. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Clinical nodal stages including cN2b and cN3 or pathologic nodal stages including pN0(i+), pN2b, pN3b with clinically apparent internal mammary nodes, or pN3c. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Suspicious nodes in the contralateral axilla or suspicious supraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible). Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Treatment, including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. One exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy. A second exception is radiation therapy for patients enrolled in NSABP B-39 and assigned to partial breast irradiation (Group 2). These patients may have received RT prior to B-38 study entry. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Prior therapy with anthracyclines or taxanes for any malignancy. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen-receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Cardiac disease that would preclude the use of anthracyclines. This includes: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | history of myocardial infarction documented by elevated cardiac enzymes or regional wall abnormalities on assessment of left ventricular (LV) function; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | angina pectoris that requires the use of anti-anginal medication; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | any history of documented congestive heart failure; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | serious cardiac arrhythmia requiring medication; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | severe conduction abnormality; Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | valvular disease with documented cardiac function compromise; and Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | uncontrolled hypertension defined as blood pressure greater than 160/100 on antihypertensive therapy. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Conditions that would prohibit administration of corticosteroids. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from receiving any of the treatment options or would prevent prolonged follow-up. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | History of hepatitis B or C. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Concurrent treatment with other investigational agents for the treatment of breast cancer. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Special conditions for ineligibility of lumpectomy patients: radiation therapy and surgery Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | For patients treated by lumpectomy, whole breast irradiation is required. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | The following patients will be ineligible: Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients with diffuse tumors (as demonstrated on mammography) treated with lumpectomy. (These patients are eligible if they undergo mastectomy.) Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
97812fde-57f3-4299-be34-dd436757adde | Patients in whom the margins of the resected specimen are involved with invasive tumor or DCIS. Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Pathologically confirmed HER2-positive MBC Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Stable systemic disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: LVEF at least 50% Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Adequate hematologic, renal, and hepatic function Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Life expectancy more than 12 weeks Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Progression of systemic disease at Screening Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Leptomeningeal disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: History of intolerance or hypersensitivity to study drug Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Use of certain investigational therapies within 21 days prior to enrollment Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Current anthracycline use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Active infection Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Pregnant or lactating women Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Significant history or risk of cardiac disease Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: Symptomatic intrinsic lung disease or lung involvement Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |
f37774f4-db96-4aa6-b3a1-626953faeecf | primary trial: Postmenopausal women, Stage III or axillary node positive secondary trial: History of other malignancy within the last 5 years Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial. | 1 |