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Cisplatin + RT for Triple Negative Breast Cancer

This study is currently recruiting participants.
Verified April 2013 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Jennifer Bellon, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01674842
First received: August 23, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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.

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.


Condition Intervention Phase
Breast Cancer
 Radiation: Radiation Therapy
Drug: Cisplatin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Safety of Cisplatin w/ Radiation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Local recurrence at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To assess long-term toxicity in participants receiving cisplatin concurrently with radiation


Estimated Enrollment: 39
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CDDP

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary tumor is triple negative breast cancer
  • Breast-conserving surgery 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674842

Contacts
Contact: Jennifer Bellon, MD 6176323591 jbellon@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer Bellon, MD     617-632-3591     jbellon@partners.org    
Principal Investigator: Jennifer Bellon, MD            
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer Bellon, MD     617-632-3591     jbellon@partners.org    
Principal Investigator: Jennifer Bellon, MD            
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jennifer R Bellon, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer Bellon, Principal Invstigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01674842     History of Changes
Other Study ID Numbers: 12-283
Study First Received: August 23, 2012
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Triple negative
Stage II
Stage III

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013