Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

Not Applicable

• Conditions: -C509 Breast, unspecified; Breast, unspecified; C509

• Registration Number: PER-062-06
• Lead Sponsor: INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>Measure:Free survival of events.<br>Timepoints:At 5 years.<br>