Cisplatin + RT for Triple Negative Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01674842

Run by

Dana-Farber Cancer Institute

People needed

55

Starts

2012-10-01

Expected to finish

2021-06-08

Last updated by the study team

2021-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber at Milford — Milford, Massachusetts, United States
• Dana Farber at South Shore Hospital — Weymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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