Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00130533|
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : October 25, 2019
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Capecitabine||Phase 3|
Patients will be stratified as per investigational site, previous adjuvant chemotherapy (anthracyclines versus anthracyclines plus taxanes), and number of affected axillary lymph nodes (0, 1-3, >= 4). Node negative patients must present a tumour size > 2 cm to be eligible. At least 6 lymph nodes must be analysed to confirm the number of affected nodes. Patients will be randomised to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice a day (p.o. bid) for 14 days, followed by a 7 day rest versus observation.
Tissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins (CK) 5/6 and epidermal growth factor receptor (EGFR) status.
The following data were obtained from the database of the "El Alamo" project. One thousand six hundred and twenty-seven (1,627) in total were considered during the years 1990 to 1997. The population is formed of patients with operable breast cancer, with surgery, positive nodes, and negative hormone receptors, or negative nodes, negative hormone receptors and T2-3 tumors.
For these patient groups, estimated 5-year disease-free survival is 64.72%. Assuming an exponential distribution, the aim is to detect an increase of 64.72% to 73.7% in 5 years Disease Free survival rate corresponds to a Hazard Ratio of 0.701 and a risk reduction of about 30%, with a power of 80% using a two-tailed log-rank test at 0.05 and whereas 4 years of recruitment period and 3 years of follow-up period. We would need 255 events, 834 patients without considering any dropouts.
Considering a drop-out rate of 5% post-randomization, the final sample size will be 876 patients, 438 per treatment arm.
The sample size calculation was performed by the program package "EAST" version 5.2.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||876 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients|
|Actual Study Start Date :||January 2006|
|Actual Primary Completion Date :||February 17, 2017|
|Actual Study Completion Date :||February 17, 2017|
Experimental: Xeloda (capecitabine)
1000 mgrs/m2 twice a day, tablets, 8 cycles
Other Name: Xeloda
No Intervention: Observation
Observation. No intervention.
- Disease Free Survival (DFS) Events [ Time Frame: 5 years ]DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
- Disease Free Survival (DFS) Events by Phenotype [ Time Frame: 5 years ]DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
- Overall Survival (OS) Event [ Time Frame: 5 years ]OS event is defined as the death from any cause.
- The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: 5 years ]Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
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): NCT00130533
|Principal Investigator:||Study Principal Investigator||Hospital Clínico Universitario de Valencia|