A Phase 2 interventional study of Cisplatin in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-31.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.
Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery.
Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment.
After completion of cisplatin, patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast.
Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation.
Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs. After surgery patients will receive standard adjuvant therapy based on discussion with their physician. Follow-up progress will occur for several years.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 27 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cisplatin 75mg/m2 q21 days x 4 pre-surgery
Drug: Cisplatin
Intravenously once every three weeks for a total of 12 weeks
To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients
To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population
Plan to share: No
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute