NCT02124902

Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis. Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel
DRUG	Carboplatin
PROCEDURE	FDG-PET/MR	* Prior to initialization of Cycle 1 and completion of cycle 1 (preferably on cycle 2 day 1) * This is not optional for final 30 participants enrolled on the study

Timeline

• Start date: 2014-07-07
• Primary completion: 2021-11-10
• Completion: 2021-12-31
• First posted: 2014-04-28
• Last updated: 2022-11-07
• Results posted: 2022-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study