Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
This is a prospective, open-label, randomized phase III study. 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-label, Randomized Phase III Trial, to Evaluate Efficacy of Maintenance Treatment With Capecitabine (X) Following Standard Adjuvant Chemotherapy, in Operable Breast Cancer Patients With Negative Hormone Receptor, Negative HER2 Tumours|
- Disease free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity profile [ Designated as safety issue: Yes ]Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AEs grade will be defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
- Chemotherapy-related amenorrhea [ Designated as safety issue: Yes ]
- Single nucleotide polymorphisms (SNPs) predicting response to capecitabine [ Designated as safety issue: No ]
- 5-year disease free survival [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
|Experimental: Xeloda (capecitabine)||
1000 mgrs/m2 twice a day, tablets, 8 cycles
|No Intervention: Observation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130533
|Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA)|
|San Sebastián de los Reyes, Madrid, Spain, 28703|