- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010140
Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining chemotherapy with hormone therapy may kill more tumor cells.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, W12 0NN
- Charing Cross Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Disease-free survival
|
Incidence of thromboembolic events during the first 9 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
---|
Quality of life
|
Tolerability
|
Collaborators and Investigators
Investigators
- Study Chair: R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci, Hammersmith Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Docetaxel
- Epirubicin
- Tamoxifen
Other Study ID Numbers
- CDR0000068450
- ICCG-C/14/96
- EU-20040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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