Cisplatin + RT for Triple Negative Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Radiation Therapy; Drug: Cisplatin

• Registration Number: NCT01674842
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-29
• Study Start: 2012-10
• Primary Completion: 2018-08
• Study Completion: 2021-06-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin + Radiation Therapy	Radiation Therapy	Cisplatin concurrently with radiation therapy
Cisplatin + Radiation Therapy	Cisplatin	Cisplatin concurrently with radiation therapy

Primary Outcome Measures

Name	Time	Method
Safety of Cisplatin w/ Radiation	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Local recurrence at 5 years	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.
Long term toxicity	2 years	To assess long-term toxicity in participants receiving cisplatin concurrently with radiation

Trial Locations

Locations (5)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber at Milford; 🇺🇸 Milford, Massachusetts, United States

Dana Farber at South Shore Hospital; 🇺🇸 Weymouth, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States