Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
3상
진행 중(모집 완료)
NCT02445391
| 대상 질환 | Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative |
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| 임상 단계 | 3상 |
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| 스폰서 | ECOG-ACRIN Cancer Research Group |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 415 명 |
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| 중재(약물) | Capecitabine, Carboplatin, Cisplatin |
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| 시작일 | 2015년 10월 20일 |
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| 완료일 | 2021년 4월 7일 |
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| 결과 공개일 | 2022년 10월 5일 |
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요약
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, 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 cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years. · percentage of participants
| Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 42.0 percentage of participants |
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| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 49.4 percentage of participants |
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| Hazard Ratio (HR) | 1.06 (95% CI 0.62–1.81) |
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