Breast Cancer Clinical Trial

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Cisplatin + RT for Triple Negative Breast Cancer

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Summary

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

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Full Description

This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.

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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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

55

Study ID:

NCT01674842

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

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There are 4 Locations for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Dana-Farber at Milford
Milford Massachusetts, 01757, United States
Dana Farber at South Shore Hospital
Weymouth Massachusetts, 02190, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

55

Study ID:

NCT01674842

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

How clear is this clinincal trial information?

Clinical Trial Resources

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