Cisplatin + RT for Triple Negative Breast Cancer

August 23, 2021 updated by: Jennifer Bellon, Dana-Farber Cancer Institute

A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cisplatin + Radiation Therapy
Cisplatin concurrently with radiation therapy
Radiation: Radiation Therapy
Once daily, Monday - Friday for six weeks
Drug: Cisplatin
Intravenously, once weekly for six weeks
Other Names:
  • CDDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Cisplatin w/ Radiation
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence at 5 years
Time Frame: 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.
5 years
Long term toxicity
Time Frame: 2 years
To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Jennifer R Bellon, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

June 8, 2021

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe