Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
NCT ID: NCT00010140
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
1997-08-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and tamoxifen with or without docetaxel in treating postmenopausal women who have breast cancer that has spread to the lymph nodes.
Detailed Description
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* Compare the impact of adjuvant epirubicin with or without docetaxel and concurrent or sequential tamoxifen on time to relapse and overall survival in postmenopausal women with node-positive breast cancer.
* Compare the toxic effects of these regimens in this patient population.
* Compare the quality of life in terms of shift in long term toxicity and differences in recuperation in women treated with these regimens.
* Compare the incidence of thromboembolic events during the first 9 months of study and the influence of such events on compliance in women treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two adjuvant chemotherapy treatment arms within 30 days after surgery.
* Arm I: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 6 courses.
* Arm II: Patients receive adjuvant epirubicin IV on days 1 and 8. Treatment continues every 28 days for 3 courses. Patients then receive docetaxel IV over 1 hour on day 1. Treatment continues every 21 days for 3 courses.
Patients may be further randomized to one of two tamoxifen arms. Patients not randomized to the tamoxifen arms receive oral tamoxifen daily for 5 years concurrently with adjuvant chemotherapy.
* Arm I: Patients receive tamoxifen as above concurrently with adjuvant chemotherapy.
* Arm II: Patients receive sequential tamoxifen as above after completion of adjuvant chemotherapy.
Quality of life is assessed at baseline, 9 months, 2 years, and then at 5 years.
Patients are followed at 9 months, 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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docetaxel
epirubicin hydrochloride
tamoxifen citrate
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven node-positive breast cancer
* Postmenopausal
* Last menstrual period more than 12 months before initial surgery OR
* Any age with prior bilateral oophorectomy OR
* Age 50 or over with prior hysterectomy without oophorectomy (unrelated to malignancy)
* No distant metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* See Disease Characteristics
Sex:
* Female
Menopausal status:
* See Disease Characteristics
Performance status:
* WHO (ECOG) 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm3 OR
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin normal
* SGOT and SGPT no greater than 1.5 times normal
* Alkaline phosphatase no greater than 1.5 times normal
Renal:
* Creatinine less than 1.5 times normal
Cardiovascular:
* No history of significant angina, congestive heart failure, or myocardial infarction within the past year
* No clinically significant arrhythmias or uncontrolled hypertension
* LVEF normal by MUGA, LV gated scan, or echocardiogram
Other:
* No other concurrent serious illness
* No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
FEMALE
No
Sponsors
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International Collaborative Cancer Group
OTHER
Principal Investigators
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R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci
Role: STUDY_CHAIR
Hammersmith Hospitals NHS Trust
Locations
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Charing Cross Hospital
London, England, United Kingdom
Countries
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Other Identifiers
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ICCG-C/14/96
Identifier Type: -
Identifier Source: secondary_id
EU-20040
Identifier Type: -
Identifier Source: secondary_id
CDR0000068450
Identifier Type: -
Identifier Source: org_study_id