A Phase II Trial of Cisplatin in Early Stage ER-, PR-, 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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients
Judy E. Garber, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|