CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 147 enrolled
Drug / intervention
Cisplatin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Pathologically confirmed invasive breast cancer by biopsy
  • ✓AJCC clinical stage I (T>1.5 cm), stage II, or stage III invasive breast cancer
  • ✓HER2-negative defined as HER2 0 or 1+ by IHC and/or lack of gene amplification by FISH (ratio <2)
  • ✓ER and PR negative (≤5% staining) by local review
Key exclusion· 5
  • ✕Prior chemotherapy, hormonal therapy, radiation, or experimental therapy for the current breast cancer
  • ✕Peripheral neuropathy of any grade >1 (NCI CTCAE v4.0)
  • ✕Significant hearing loss that would prevent cisplatin administration
  • ✕Renal dysfunction (creatinine >1.5 mg/dl or GFR <60 cc/min) precluding safe cisplatin use

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

Search/NCT01982448
NCT01982448Phase 2Completed
CompareCT.gov

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

Dana-Farber Cancer Institute·interventional·Posted Nov 13, 2013·Updated Sep 30, 2025

In Brief

A Phase 2 clinical trial evaluating Cisplatin and Paclitaxel for Triple Negative Breast Cancer. Completed, enrolled 147 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Cancer
CountriesUnited States
CollaboratorsMyriad Genetics, Inc., Translational Breast Cancer Research Consortium

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartApr 1, 2014
Primary CompletionJan 1, 2019
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.6 years ago

Interventions

Cisplatindrug

Paclitaxeldrug