Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer (CAP7/7)
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|ClinicalTrials.gov Identifier: NCT02028494|
Recruitment Status : Unknown
Verified September 2018 by Latin American & Caribbean Society of Medical Oncology.
Recruitment status was: Recruiting
First Posted : January 7, 2014
Last Update Posted : September 7, 2018
The purpose of this study is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer.
Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug and previous studies done al Memorial Sloan Kettering Cancer Center support the tolerability of this scheme.
This definitive, randomized trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer is necessary and we hypothesize it will be superior in terms of efficacy.
Dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. This trial is a proof of principle trial of the highest priority.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Capecitabine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
Experimental: Arm A: Capecitabine 2,000 mg (flat dose)
Arm A: Capecitabine 2,000 mg (flat dose), orally, twice daily for 7 days followed by a 7 day rest (7-7) (4-week cycle length ).
Two dosages comparison
Other Name: Xeloda
Active Comparator: Arm B: Capecitabine 1,000 mg/m2 twice daily for 14 day
Arm B: Capecitabine 1,000 mg/m2, orally, twice daily for 14 days followed by a 7 day rest (14-7) (3-week cycle length ). The control arm dose of capecitabine has been reduced from the US Food and Drug Administration approved dose of 1,250 mg/m2, orally, twice daily due to common clinical practice.
Two dosages comparison
Other Name: Xeloda
- Progress Free Survival (PFS) [ Time Frame: 24 month ]The primary endpoint of this study is PFS, defined as the time from treatment start to progression or last date of follow-up. PFS will be estimated using Kaplan-Meier methods. This will be an intention to treat analysis. The Log-rank test will be used to test whether PFS is different for the two capecitabine schedules. It is hypothesized that the 7-7 schedule of capecitabine will have superior efficacy.
- Number of participants with toxicity. [ Time Frame: 24 month ]
- To assess and compare tolerability of the two capecitabine schedules in terms of selected hematologic and non-hematologic toxicities.
- To compare the rates of grade 3 or greater diarrhea, nausea and vomiting between the two schedules.
- Number of patients with treatment delays. [ Time Frame: 24 month ]
- Number of patients with dose reduction. [ Time Frame: 24 month ]
- Number of patients with study withdrawal. [ Time Frame: 24 month ]
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): NCT02028494
|Contact: Daniel Campos, MDfirstname.lastname@example.org|
|Buenos Aires, Argentina, 1120|
|Study Chair:||Eduardo Cazap, MD,PhD||Latin American & Caribbean Society of Medical Oncology|
|Study Chair:||Tiffany Traina, MD||MSKCC|