NCT01752686

A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 587 (estimated)
• Sponsor: Severance Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.

Detailed description

In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals. In POST Neo-adjuvant period Randomization: At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	carboplatin as adjuvant chemotherapy

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-03-01
• Completion: 2018-03-01
• First posted: 2012-12-19
• Last updated: 2012-12-25