Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)
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|ClinicalTrials.gov Identifier: NCT01126138|
Recruitment Status : Unknown
Verified May 2010 by Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : May 19, 2010
Last Update Posted : May 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Invasive Ductal, Breast||Drug: Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine Drug: Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||August 2015|
Vinorelbine plus Capecitabine
Drug: Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine
Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) Vinorelbine: 25 mg/m2 IV over 3 hours on day 1 and 8, every 3 weeks 21 days as one cycle and 6 cycles are required
Docetaxel plus Capecitabine
Drug: Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine
Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel: 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6 cycles are required.
Followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity
- Progression free survival(PFS) [ Time Frame: Up to 2 years until disease progression or death ]
Progress free survival is defined as the time from first dose of test drug to the first recording of disease progression or the date of death in patients with no evidence of disease progression.
In addition to hazard ratios and associated 95% confidence intervals, the results from these analyses will, for each treatment arm, also be summarized by Kaplan-Meier plots, medians and 95% confidence intervals.
- Safety Profiles [ Time Frame: Up to 2 years until 28 days after last intake of study medication ]
All adverse events occurring up to 28 days after last intake of study medication are to be recorded in the case report form. Safety profile will be analyzed by tabulating its occurring frequency and percentage per patient using NCI-CTC version 3.0. χ2 statistics will be used to test the differences in toxicities between the two treatment arms.
SAEs will be reported according to ICH-GCP.
- Overall Survival [ Time Frame: Up to 3 years after last intake of study medication ]Survival will be measured from the date of first dose of test drug to the date of death (any cause) or to the date of last contact.
- Response Rate [ Time Frame: Up to 2 years until disease progression, unacceptable toxicity or death ]Tumor responses were assessed on the basis of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at 6-week intervals then at 12-week intervals after disease progression.
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): NCT01126138
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 100021|
|Contact: Binghe Xu, MD, Ph.D +86-10-87788826 email@example.com|
|Contact: Jiayu Wang, MD +86-13641238489 firstname.lastname@example.org|
|Principal Investigator: Binghe Xu, MD, Ph.D|
|Sub-Investigator: Jiayu Wang, MD|
|Principal Investigator:||Binghe Xu, MD, Ph.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|