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Cisplatin + RT for Triple Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT01674842
Recruitment Status : Recruiting
First Posted : August 29, 2012
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Bellon, 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


Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation Therapy Drug: Cisplatin Phase 1

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  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

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 Name: CDDP



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Long term toxicity [ Time Frame: 2 years ]
    To assess long-term toxicity in participants receiving cisplatin concurrently with radiation



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674842


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

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven J Isakoff, MD PHD    617-726-6500    sisakoff@partners.org   
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer Bellon, MD    617-632-3591    jbellon@partners.org   
Principal Investigator: Jennifer Bellon, MD         
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         
Dana-Farber at Milford Recruiting
Milford, Massachusetts, United States, 01757
Contact: Tatiana Lingos, MD    508-488-3835    tlingos@partners.org   
Dana Farber at South Shore Hospital Recruiting
Weymouth, Massachusetts, United States, 02190
Contact: Tatiana Lingos, M.D.    781-624-4700    tlingos@partners.org   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jennifer R Bellon, MD Dana-Farber Cancer Institute

Responsible Party: Jennifer Bellon, Principal Invstigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01674842     History of Changes
Other Study ID Numbers: 12-283
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Antineoplastic Agents