Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
3상
진행 중(모집 완료)
NCT01272037
| 대상 질환 | Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma |
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| 임상 단계 | 3상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 5,018 명 |
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| 중재(약물) | Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment |
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| 시작일 | 2011년 2월 28일 |
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| 완료일 | 2023년 2월 1일 |
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| 결과 공개일 | 2023년 6월 27일 |
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요약
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 |
| Hazard Ratio (HR) | 1.02 (95% CI 0.98–1.05) |
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