Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Phase 3
Active, not recruiting
NCT01272037
| Condition | Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma |
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| Phase | Phase 3 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 5,018 participants |
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| Interventions | Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment |
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| Start date | Feb 28, 2011 |
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| Completion date | Feb 1, 2023 |
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| Results posted | Jun 27, 2023 |
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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.
Invasive Disease-Free Survival (IDFS)
5 years after randomization · percentage of participants
| Chemo and Endocrine Therapy | 93.9 percentage of participants |
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| Endocrine Therapy Alone | 89.0 percentage of participants |
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| Chemo and Endocrine Therapy | 91.3 percentage of participants |
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| Endocrine Therapy Alone | 91.9 percentage of participants |
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| p-value | 0.35 |
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| Hazard Ratio (HR) | 1.02 (95% CI 0.98–1.05) |
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Open in BENITIONS
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