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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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 radiation to determine the
toxicity of this combined treatment and establish an MTD.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of Cisplatin w/ Radiation

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jennifer R Bellon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

12-283

NCT ID:

NCT01674842

Start Date:

October 2012

Completion Date:

October 2017

Related Keywords:

  • Breast Cancer
  • Triple negative
  • Stage II
  • Stage III
  • Breast Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115