Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
Phase 3
Active, not recruiting
NCT02445391
| Condition | Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative |
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| Phase | Phase 3 |
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| Sponsor | ECOG-ACRIN Cancer Research Group |
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| Status | Active, not recruiting |
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| Enrollment | 415 participants |
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| Interventions | Capecitabine, Carboplatin, Cisplatin |
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| Start date | Oct 20, 2015 |
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| Completion date | Apr 7, 2021 |
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| Results posted | Oct 5, 2022 |
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Summary
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) |
Open in BENITIONS
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