BENITIONSClinical Trial Intelligence

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

3상 진행 중(모집 완료) NCT02445391

대상 질환Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative
임상 단계3상
스폰서ECOG-ACRIN Cancer Research Group
상태진행 중(모집 완료)
참여자 수415 명
중재(약물)Capecitabine, Carboplatin, Cisplatin
시작일2015년 10월 20일
완료일2021년 4월 7일
결과 공개일2022년 10월 5일

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
Arm C (Capecitabine) (Open to Accrual 6/22/2016)49.4 percentage of participants
Hazard Ratio (HR)1.06 (95% CI 0.62–1.81)

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