Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432172
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2007-02-06
Brief Title:
Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 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 an open-label study that includes two substudies of random distribution Firsta sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markersDepending on the expression of these markers the patients will be characterize as group 1 Luminal A phenotype or group 2 Basal phenotype and a random assignment will be performed to standard or experimental treatment
Detailed Description:
Group 1 Luminal A
Standard treatment Epirubicin E 90 mg m2 intravenous iv in combination with Cyclophosphamide C 600 mg m2 iv every 21 days for 4 cycles followed by docetaxel D100 mgm2 iv every 21 days for 4 cycles
EC x 4 - D x 4
Selective treatment Postmenopausal patients exemestane x 6 months Premenopausal patients goserelin x 6 months exemestane x 6 months
Group 2 Basal
Standard treatment EC x 4 - D x 4
Selective treatment E 90 mg m2 iv in combination with C 600 mg m2 iv every 21 days for 4 cycles followed by D 75 mgm2 and carboplatin Cb area under the curve 6 mgmL iv every 21 days for 4 cycles
EC x 4 - DCb x 4
Standard treatment Epirubicin E 90 mg m2 intravenous iv in combination with Cyclophosphamide C 600 mg m2 iv every 21 days for 4 cycles followed by docetaxel D100 mgm2 iv every 21 days for 4 cycles
EC x 4 - D x 4
Selective treatment Postmenopausal patients exemestane x 6 months Premenopausal patients goserelin x 6 months exemestane x 6 months
Group 2 Basal
Standard treatment EC x 4 - D x 4
Selective treatment E 90 mg m2 iv in combination with C 600 mg m2 iv every 21 days for 4 cycles followed by D 75 mgm2 and carboplatin Cb area under the curve 6 mgmL iv every 21 days for 4 cycles
EC x 4 - DCb x 4
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