Spots Global Cancer Trial Database for Preoperative Cisplatin in Early Stage Breast Cancer

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Trial Identification

Brief Title: Preoperative Cisplatin in Early Stage Breast Cancer

Official Title: A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer

Study ID: NCT00148694

Conditions

Breast Cancer

Interventions

Cisplatin

Study Description

Brief Summary: 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.

Detailed Description: 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.