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

August 23, 2012
April 23, 2013
October 2012
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01674842 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Cisplatin + RT for Triple Negative Breast Cancer
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.

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.

This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: Radiation Therapy
    Once daily, Monday - Friday for six weeks
  • Drug: Cisplatin
    Intravenously, once weekly for six weeks
    Other Name: CDDP
Experimental: Cisplatin + Radiation Therapy
Cisplatin concurrently with radiation therapy
Interventions:
  • Radiation: Radiation Therapy
  • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
39
October 2017
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jennifer Bellon, MD 6176323591 jbellon@partners.org
United States
 
NCT01674842
12-283
Yes
Jennifer Bellon, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Jennifer R Bellon, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP