NCT01674842

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Once daily, Monday - Friday for six weeks
DRUG	Cisplatin	Intravenously, once weekly for six weeks

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-08-01
• Completion: 2021-06-08
• First posted: 2012-08-29
• Last updated: 2021-08-25

Locations

5 sites across 1 country: United States