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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 26, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT01272037). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 5018 participants (ACTUAL). Conditions: Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma. Interventions: DRUG: Anastrozole; DRUG: Exemestane; OTHER: Laboratory Biomarker Analysis; DRUG: Letrozole; OTHER: Quality-of-Life Assessment; DRUG: Systemic Chemotherapy; DRUG: Tamoxifen Citrate. Primary outcome measures: Invasive Disease-Free Survival (IDFS) , 5 years after randomization. Brief summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.