Status:
COMPLETED
Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Female patients with adenocarcinoma of the breast confirmed by biopsy
- Age 65 or older
- Under age 65 must have significant medical illness, or general frailty
- Adequate bone marrow, liver or kidney function
- Normal heart function
- Less than 84 days from mastectomy/lumpectomy or axillary dissection
- Signed consent obtained prior to initiation of any study procedures
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Received neo-adjuvant therapy
- Primary tumor is locally advanced at diagnosis
- Received prior chemotherapy within five years
- Received previous radiation therapy within 5 years
- Peripheral neuropathy
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2004
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00193011
Start Date
March 1 2002
End Date
August 1 2004
Last Update
May 3 2011
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