Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193011
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2005-09-12
Brief Title:
Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Randomized Multicenter Trial Comparing Weekly Docetaxel and CMF in the Adjuvant Treatment of Women With High-Risk Breast Cancer Who Are 65 Years Old or Are Not Candidates for Anthracycline-Based Adjuvant Therapy
Status:
COMPLETED
Status Verified Date:
2011-05
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 trial will evaluate the effectiveness of standard adjuvant treatment with CMF chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens This CMF regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer however the patient population in this trial has tolerated more intensive CMF regimens poorly in other trials
Detailed Description:
Upon determination of eligibility patients will be randomly assigned to one of two treatment arms
Docetaxel
Cyclophosphamide Methotrexate 5-fluorouracil
This is not a blinded study so both the patient and the investigator will know which treatment has been assigned
Chemotherapy will be followed by breast andor regional radiotherapy in appropriate patients and by hormone therapy with tamoxifen for 5 years in patients who are estrogen-receptor positive Patients who are considered poor candidates to receive tamoxifen may receive hormonal therapy with anastrazole
Docetaxel
Cyclophosphamide Methotrexate 5-fluorouracil
This is not a blinded study so both the patient and the investigator will know which treatment has been assigned
Chemotherapy will be followed by breast andor regional radiotherapy in appropriate patients and by hormone therapy with tamoxifen for 5 years in patients who are estrogen-receptor positive Patients who are considered poor candidates to receive tamoxifen may receive hormonal therapy with anastrazole
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 |
|---|---|---|---|
| GIA 11169 | None | None | None |