Cisplatin + RT for Triple Negative Breast Cancer

Description

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.

Study Start Date

October 2012

Estimated Completion Date

October 2018

Interventions

  • Drug: Cisplatin
  • Radiation: Radiation Therapy

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast,Pharmacology/Therapy,Radiation Oncology
  • Radiology: Radiotherapy (XRT)
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Breast Neoplasms
  • Cisplatin
  • Radiotherapy

Study ID

Dana-Farber Cancer Institute -- 12-283

Status

Unknown

Trial ID

NCT01674842

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

39

Sponsor

Dana-Farber Cancer Institute

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Dana Farber at South Shore Hospital - Weymouth, Massachusetts 4.5 miles None None None
Dana Farber at South Shore Hospital - Weymouth, Massachusetts 4.5 miles Tatiana Lingos MD 781-624-4700 tlingos@partners.org
DanaFarber at Milford - Milford, Massachusetts 26.3 miles Tatiana Lingos MD 508-488-3835 tlingos@partners.org
DanaFarber at Milford - Milford, Massachusetts 26.3 miles None None None

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