OncRef

Clinical Trial: NCT01982448

Cisplatin vs Paclitaxel for Triple Negative Breast Cancer

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Dana-Farber Cancer Institute
Information Provided By:Dana-Farber Cancer Institute
Last Update Posted:2025-09-30

Study Overview

Brief Summary

This is a phase II study randomizing patients with stage I with T1 > 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic response to preoperative chemotherapy.

Official Title

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker

Conditions

Triple Negative Breast Cancer

Intervention / Treatment

  • Drug: Cisplatin
  • Drug: Paclitaxel

Other Study ID Numbers

  • 13-383
  • TBCRC030

Start Date

2014-04

Primary Completion Date (Actual)

2019-01

Study Completion Date (Actual)

2020-08

Enrollment (Actual)

147

Study Type

Interventional

Phase

Phase 2