NCT01982448

Cisplatin vs Paclitaxel for Triple Negative Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cisplatin and paclitaxel are active in triple-negative breast cancer (TNBC). Despite different mechanisms of action, effective predictive biomarkers to preferentially inform drug selection have not been identified. The homologous recombination deficiency (HRD) assay (Myriad Genetics, Inc.) detects impaired double-strand DNA break repair and may identify patients with BRCA1/2-proficient tumors that are sensitive to DNA-targeting therapy. The primary objective of TBCRC 030 was to detect an association of HRD with pathologic response (residual cancer burden (RCB)-0/1) to singleagent cisplatin or paclitaxel. This prospective phase II study enrolled patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC in a 12-week randomized study of preoperative cisplatin or paclitaxel. The HRD assay was carried out on baseline tissue; positive HRD was defined as a score \>=33. Crossover to an alternative chemotherapy was offered if there was inadequate response.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin
DRUG	Paclitaxel

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-01-01
• Completion: 2020-08-01
• First posted: 2013-11-13
• Last updated: 2025-09-30
• Results posted: 2021-06-18

Locations

20 sites across 1 country: United States