Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel Drug: epirubicin hydrochloride Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients |
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Incidence of thromboembolic events during the first 9 months after randomization [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
| Study Start Date: | August 1997 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Charing Cross Hospital | |
| London, England, United Kingdom, W12 0NN | |
| Study Chair: | R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci | Hammersmith Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00010140 History of Changes |
| Other Study ID Numbers: | CDR0000068450, ICCG-C/14/96, EU-20040 |
| Study First Received: | February 2, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epirubicin Docetaxel Tamoxifen Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013