Cisplatin + RT for Triple Negative Breast Cancer

Dana-Farber Cancer Institute55 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Radiation TherapyRADIATION

Once daily, Monday - Friday for six weeks

CisplatinDRUG

Intravenously, once weekly for six weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Safety of Cisplatin w/ Radiation

To determine the maximum tolerated dose 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.

Time frame: 2 years

Secondary Outcomes

Local recurrence at 5 years

To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.

Time frame: 5 years

Long term toxicity

To assess long-term toxicity in participants receiving cisplatin concurrently with radiation

Time frame: 2 years

Data from ClinicalTrials.gov

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