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Cisplatin + RT for Triple Negative Breast Cancer

Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01674842 (View complete trial on
DFCI Protocol ID: 12-283


This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, DF/BWCC at South Shore Hospital

Overall PI:
Jennifer Bellon, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Steven Isakoff, MD, PhD, Massachusetts General Hospital
Tatiana Lingos, MD, Dana Farber Cancer Institute at South Shore Hospital

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Primary tumor is triple negative breast cancer - Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins - Pathologic or clinical stage II or III disease - At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks) Exclusion Criteria: - Pregnant or breastfeeding - Prior radiation to breast or ipsilateral regional nodes - Ongoing therapy with other investigational agents - Hormonal therapy - Significant co-morbidity - Pathologic complete response following preoperative chemotherapy - Biopsy proven metastatic disease
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