None listed
Conditions
Interventions
Patients in this group will receive the study treatment after systemic chemotherapy. If radiotherapy is needed, it may be given during the study treatment or after finishing it. Exemestane 25 mg, PO, QD, will be administered for 5 years
Group name:BRANCH 2 Type of group
Patients in this group will receive the study treatment after systemic chemotherapy. If radiotherapy is needed, it may be given during the study treatment or after finishing it. Anastrozole 1 mg, PO, QD, will be administered for 5 years.
Sponsors
INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proven invasive breast cancer, resected in the following TNM categories: pT1, pT2 or pT3; pNx, pN0, pN1, pN2 or, only when the only basis for this classification is the presence of 10 axillary nodes or more, pN3; M0. Surgical margins should be free of invasive carcinoma and DCIS. 2) The primary tumor must be a positive receptor. 3) Postmenopausal condition prior to chemotherapy. 4) Patients with bilateral breast cancers will be eligible only if their cancers are synchronous. 5) Patients must have had a bilateral mammogram within 12 months before randomization. 6) Radiological investigations must be negative for metastasis. 7) Patients should be randomized in a minimum of 3 weeks and a maximum of 3 months after the end of chemotherapy. If no chemotherapy is given, patients should be recruited at a minimum of 3 weeks and no more than 3 months after the first surgery. 8) Minimum life expectancy of 5 years. 9) Hematology: Leukocytes> 3.0 x 10-9 / L or granulocytes (polymorphs + juveniles)> 1.5 x 10-9 / L; platelets> 100 x 10-9 / L within 4 weeks before randomization. 10) Biochemistry: AST (SGOT) and / or ALT (SGPT) and alkaline phosphatase <2 x at the upper institutional normal limit (UNL). 11) Performance status ECOG 0, 1, or 2. 12) The patient should be able to swallow the study medication and have adequate swallowing to maintain a reasonable state of nutrition. 13) Patients must be eligible for treatment and follow-up. Researchers should ensure that randomized patients in this study will be available for complete documentation of treatment, toxicity and follow-up. 14) The consent of the patient must be obtained according to the Institutional requirements and / or the Ethics Committees. 15) The treatment of the study should begin within 10 working days after the randomization.
Exclusion criteria
Exclusion criteria: 1) Patients with histologically proven invasive breast cancer, resected in the following TNM categories: pT1, pT2 or pT3; pNx, pN0, pN1, pN2 or, only when the only basis for this classification is the presence of 10 axillary nodes or more, pN3; M0. Surgical margins should be free of invasive carcinoma and DCIS. 2) The primary tumor must be a positive receptor. 3) Postmenopausal condition prior to chemotherapy. 4) Patients with bilateral breast cancers will be eligible only if their cancers are synchronous. 5) Patients must have had a bilateral mammogram within 12 months before randomization. 6) Radiological investigations must be negative for metastasis. 7) Patients should be randomized in a minimum of 3 weeks and a maximum of 3 months after the end of chemotherapy. If no chemotherapy is given, patients should be recruited at a minimum of 3 weeks and no more than 3 months after the first surgery. 8) Minimum life expectancy of 5 years. 9) Hematology: Leukocytes> 3.0 x 10-9 / L or granulocytes (polymorphs + juveniles)> 1.5 x 10-9 / L; platelets> 100 x 10-9 / L within 4 weeks before randomization. 10) Biochemistry: AST (SGOT) and / or ALT (SGPT) and alkaline phosphatase <2 x at the upper limit of the institutional normal (UNL). 11) Performance status ECOG 0, 1, or 2. 12) The patient should be able to swallow the study medication and have adequate swallowing to maintain a reasonable state of nutrition. 13) Patients must be eligible for treatment and follow-up. Researchers should ensure that randomized patients in this study will be available for complete documentation of treatment, toxicity and follow-up. 14) The consent of the patient must be obtained according to the Institutional requirements and / or the Ethics Committees. 15) The treatment of the study should begin within 10 working days after the randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to determine the time from the moment of randomization until an event occurs, defined as locoregional or documented distance recurrence, new primary niama cancer, or death from any cause. Measure:Free survival of events. Timepoints:At 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Overall survival: Clinical evaluation to determine the time from the moment of randomization to death from any cause. 2) Time for distant recurrence: Clinical evaluation to determine the time from the moment of randomization to distant recurrence, defined as the extension of disease beyond the lymph nodes in the homolateral axilla, ipsilateral supraclavicular fossa or in the chain internal mammary ipsilateral. Recurrence should be confirmed with biopsy and / or radiological evidence. 3) Clinical fracture index: Clinical evaluation with anteroposterior and lateral radiographs of any fracture at any time, including those of the hip, spine or wrist. Measure:1) Global survival. 2) Time for remote recurrence. 3) Clinical fracture index. Timepoints:1) Global survival: 5 years. 2) Time for remote recurrence: 5 years. 3) Clinical fracture index: 8 years. ; Outcome name:Clinical evaluation of symptoms of toxicity and intercurrent diseases: According to the NCI Common Terminology for Adverse Events (CTCAE) Version 3.0. Hematological panel: white blood cells, platelets and hemoglobin. Measure:Clinical and hematological safety. Timepoints:Months 6, 12, 24, 36, 48 and 60. | — |
Countries
Australia, Hungary, Italy, Puerto Rico, South Africa, Switzerland, United States
Outcome results
None listed