Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130533
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2005-08-12
Brief Title:
Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective open-label randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer
Detailed Description:
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 mgm2 by mouth twice a day po 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 56 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 1627 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 6472 Assuming an exponential distribution the aim is to detect an increase of 6472 to 737 in 5 years Disease Free survival rate corresponds to a Hazard Ratio of 0701 and a risk reduction of about 30 with a power of 80 using a two-tailed log-rank test at 005 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 52
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 56 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 1627 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 6472 Assuming an exponential distribution the aim is to detect an increase of 6472 to 737 in 5 years Disease Free survival rate corresponds to a Hazard Ratio of 0701 and a risk reduction of about 30 with a power of 80 using a two-tailed log-rank test at 005 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 52
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-002838-36 | EUDRACT_NUMBER | None | None |