NCT02001519

Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy

A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.

Detailed description

First outcome measures (analysis) :at the time of surgery, Second outcome measures: 2019 August, 5 year Overall Survival, Disease free survival

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	AC4-CDDP4	4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks 4 cycles of cisplatin 75 mg/m2 every 3 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-02-01
• Completion: 2014-07-01
• First posted: 2013-12-05
• Last updated: 2014-12-02

Locations

1 site across 1 country: South Korea