BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT02445391

ConditionEstrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative
PhasePhase 3
SponsorECOG-ACRIN Cancer Research Group
StatusActive, not recruiting
Enrollment415 participants
InterventionsCapecitabine, Carboplatin, Cisplatin
Start dateOct 20, 2015
Completion dateApr 7, 2021
Results postedOct 5, 2022

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
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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