At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed invasive breast cancer
- ✓Clinical stage T1 (≥1.0 cm), T2, or T3; N0-3; M0 (no distant metastases)
- ✓HER2 negative status
- ✓Known ER and PgR status by immunohistochemistry; ER+ patients allowed if neoadjuvant chemotherapy deemed appropriate by physician
- ✕Pregnant or breastfeeding
- ✕Prior anthracycline or platinum-based chemotherapy
- ✕Prior treatment for current breast cancer (chemotherapy, hormonal therapy, radiation, or experimental therapy)
- ✕Peripheral neuropathy exceeding grade 1 from any cause
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations
In Brief
A Phase 2 clinical trial evaluating Cisplatin, Cyclophosphamide, and 1 other intervention for Breast Cancer. Completed, enrolled 118 participants across 15 sites.
Detailed Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.
Study Details
Timeline
Interventions
administered intravenously every 3 weeks for 4 doses
administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses