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Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010140
Recruitment Status : Unknown
Verified September 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: epirubicin hydrochloride Drug: tamoxifen citrate Procedure: adjuvant therapy Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : August 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Disease-free survival
  2. Overall survival
  3. Incidence of thromboembolic events during the first 9 months after randomization

Secondary Outcome Measures :
  1. Tolerability
  2. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • See Disease Characteristics


  • Female

Menopausal status:

  • See Disease Characteristics

Performance status:

  • WHO (ECOG) 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm3 OR
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin normal
  • SGOT and SGPT no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 1.5 times normal


  • Creatinine less than 1.5 times normal


  • 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


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010140

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United Kingdom
Charing Cross Hospital
London, England, United Kingdom, W12 0NN
Sponsors and Collaborators
International Collaborative Cancer Group
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Study Chair: R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci Hammersmith Hospitals NHS Trust

Layout table for additonal information Identifier: NCT00010140     History of Changes
Other Study ID Numbers: CDR0000068450
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: September 2005
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors