BENITIONSClinical Trial Intelligence

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

Фаза 3 Идёт, набор закрыт NCT02445391

ЗаболеваниеEstrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative
ФазаФаза 3
СпонсорECOG-ACRIN Cancer Research Group
СтатусИдёт, набор закрыт
Участники415 участн.
ВмешательствоCapecitabine, Carboplatin, Cisplatin
Дата начала20.10.2015
Дата завершения7.04.2021
Публикация результатов5.10.2022

Кратко

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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