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Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: February 2, 2001   Last Updated: February 6, 2009   History of Changes
Sponsored by: International Collaborative Cancer Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00010140
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Multicenter Randomized Trial of Sequential Epirubicin and Docetaxel Versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Tamoxifen Tamoxifen citrate Epirubicin hydrochloride Epirubicin Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Tolerability [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Study Start Date: August 1997
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010140

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000068450, ICCG-C/14/96, EU-20040
Study First Received: February 2, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00010140     History of Changes
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

Study placed in the following topic categories:
Estrogen Antagonists
Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Citric Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Adjuvants, Immunologic
Breast Neoplasms
Bone Density Conservation Agents
 Selective Estrogen Receptor Modulators
Hormones
Epirubicin
Tamoxifen
Docetaxel
Anti-Bacterial Agents
Estrogen Receptor Modulators
Citrate
Breast Diseases

Additional relevant MeSH terms:
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
 Antibiotics, Antineoplastic
Epirubicin
Tamoxifen
Pharmacologic Actions
Docetaxel
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009



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