CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Cisplatin 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01074970
NCT01074970Phase 2Completed
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PARP Inhibition After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer or ER/PR +, HER2 Negative With Known BRCA1/2 Mutations: Hoosier Oncology Group BRE09-146

Hoosier Cancer Research Network·interventional·Posted Feb 24, 2010·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Cisplatin and Rucaparib for Breast Cancer. Completed, enrolled 135 participants across 27 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsClovis Oncology, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartFeb 1, 2010
Primary CompletionDec 15, 2018
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 16.4 years ago

Interventions

Cisplatindrug

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

Rucaparibdrug

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

Cisplatindrug

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