Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01928680|
Recruitment Status : Unknown
Verified February 2015 by Li Qiao, Chinese Academy of Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2013
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Cisplatin/Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||March 2016|
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.
This is a single arm phase II clinical trial.
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
Other Name: Xeloda
- Overall Response Rate [ Time Frame: 6 months ]
- Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 3 years ]
- Number and Severity of Adverse Events of Patients Enrolled in This Trial [ Time Frame: 1 year ]Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928680
|Cancer Hospital, ChineseAMS|
|Beijing, Beijing, China, 100021|
|Principal Investigator:||Binghe XU, MD, PHD||Chinese Academy of Medical Sciences|