Cisplatin vs Paclitaxel for Triple Negative Breast Cancer

NCT01982448 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-09-26

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Cisplatin

DRUG

Paclitaxel

Sponsors & Collaborators

  • Myriad Genetics, Inc.

    collaborator INDUSTRY
  • Translational Breast Cancer Research Consortium

    collaborator OTHER
  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Erica Mayer, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2019-01-31
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01982448 on ClinicalTrials.gov