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
18 Years
N/A
Female
Breast Cancer
Trial Information
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
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 and/or 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.
Inclusion Criteria:
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 Criteria:
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease-free survival
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Denise Yardley, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
SCRI BRE 41
NCT ID:
NCT00193011
Start Date:
March 2002
Completion Date:
August 2004
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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