Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331097
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2006-05-26
Brief Title:
ELDA Elderly Breast Cancer - Docetaxel in Adjuvant Treatment
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Adjuvant Chemotherapy in Elderly Patients With Breast Cancer Weekly Docetaxel vs CMF
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy CMF versus experimental adjuvant chemotherapy weekly docetaxel
Detailed Description:
Adjuvant combination chemotherapy given after breast cancer surgery has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or high risk for recurrence However since elderly patients have been underrepresented in past clinical trials the optimal adjuvant therapy for elderly patients at risk for recurrence has not yet been defined
Docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting Administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer
In this study patients from ages 65 to 80 will be randomized to one of two treatment strategies
standard adjuvant chemotherapy with CMF cyclophosphamide methotrexate and 5-fluorouracil given intravenously on days 1 and 8 of each cycle
experimental adjuvant chemotherapy with weekly docetaxel given intravenously on days 18 and 15 of each cycle
In both treatment strategies
4 cycles of chemotherapy will administered for patients at least 10 positive for ER or PgR and 6 cycles will administered for patients expressing 10 ER or PgR
patients with any positive expression of ER or PgR will receive adjuvant hormonal therapy with tamoxifen 20mgday for 5 years after concluding chemotherapy
adjuvant radiation therapy will be given to patients who are candidates at the conclusion of chemotherapy and within 6 months of surgery
Docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting Administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer
In this study patients from ages 65 to 80 will be randomized to one of two treatment strategies
standard adjuvant chemotherapy with CMF cyclophosphamide methotrexate and 5-fluorouracil given intravenously on days 1 and 8 of each cycle
experimental adjuvant chemotherapy with weekly docetaxel given intravenously on days 18 and 15 of each cycle
In both treatment strategies
4 cycles of chemotherapy will administered for patients at least 10 positive for ER or PgR and 6 cycles will administered for patients expressing 10 ER or PgR
patients with any positive expression of ER or PgR will receive adjuvant hormonal therapy with tamoxifen 20mgday for 5 years after concluding chemotherapy
adjuvant radiation therapy will be given to patients who are candidates at the conclusion of chemotherapy and within 6 months of surgery
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