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PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations

NCT01074970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-09-19

Study results available
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Summary

The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.

Conditions

Interventions

DRUG

Cisplatin

Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles

DRUG

Rucaparib

Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles

DRUG

Cisplatin

Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles

Sponsors & Collaborators

  • Clovis Oncology, Inc.

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    lead OTHER

Principal Investigators

  • Kathy D. Miller, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2018-12-15
Completion
2018-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01074970 on ClinicalTrials.gov