NCT01928680

Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer

Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.

Detailed description

Cisplatin contained regimens have been demonstrated to be effective in metastatic triple negative breast cancer patients in some phase II clinical trials. Meanwhile, Capecitabine is also a highly effective choice for metastatic breast cancer with considerable duration of response. Combination of cisplatin and capecitabine have been proved effective in metastatic breast cancer in several phase II trials. This study is aimed to investigate the efficacy and safety of this combination in triple negative breast cancer patients.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin/Capecitabine	Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-10-01
• Completion: 2016-03-01
• First posted: 2013-08-27
• Last updated: 2015-02-23
• Results posted: 2015-02-23

Locations

1 site across 1 country: China