Status and phase
Conditions
Treatments
About
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.
Full description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
To be included in this study, you must meet the following criteria:
Exclusion criteria
You cannot participate in this study if any of the following apply to you:
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.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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