Cisplatin + RT for Triple Negative Breast Cancer
Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01674842
(View complete trial on ClinicalTrials.gov)
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. 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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Jennifer Bellon, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Eligibility Criteria
Inclusion Criteria:
- Primary tumor is triple negative breast cancer
- Breast-conserving surgery 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