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Combination Chemotherapy in Treating Women With Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: November 5, 2013
Last verified: May 2007

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus cyclophosphamide for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin in combination with either docetaxel or cyclophosphamide in treating women who have previously untreated, advanced, or inflammatory breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: tamoxifen citrate
Procedure: conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Comparative Trial of Adriamycin + Taxotere vs. Adriamycin + Cyclophosphamide as Primary Medical Therapy for Patients With Potentially Operable Breast Cancer Greater Than or Equal to 3 cm Diameter, Locally Advanced, or Inflammatory Disease

Resource links provided by NLM:

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

Estimated Enrollment: 350
Study Start Date: November 1998
Detailed Description:

OBJECTIVES: I. Compare the efficacy (response rate) and toxicity of doxorubicin in combination with either docetaxel or cyclophosphamide as primary therapy regimens in patients with locally advanced or inflammatory breast cancer.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and operability. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV followed by doxorubicin IV once every 3 weeks. Arm II: Patients receive doxorubicin IV and cyclophosphamide IV once every 3 weeks. Patients receive a maximum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Patients then undergo surgery (if operable) followed by more chemotherapy (if node positive), radiation therapy, and oral tamoxifen for 5 years (at the discretion of the investigator for estrogen receptor-negative patients). Patients are followed at 12, 18, and 24 months, and then annually for at least 5 years.

PROJECTED ACCRUAL: A total of 350 patients (175 per arm) will be accrued for this study.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven previously untreated locally advanced or inflammatory breast cancer Potentially operable disease Tumor at least 3 cm in diameter No metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 60 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: PT and aPTT normal Bilirubin normal (except in patients with benign congenital hyperbilirubinemia) AST/ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN No active hepatitis B or C Liver biopsy normal (if positive serology for hepatitis B or C) Renal: Creatinine normal Cardiovascular: Adequate cardiac function No active cardiac disease Other: Not pregnant Fertile patients must use effective contraception No other serious medical or psychiatric disease No prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior therapy for breast cancer

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Please refer to this study by its identifier: NCT00003679

United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom, G61 1BD
Sponsors and Collaborators
Scottish Cancer Therapy Network
Study Chair: T.R.J. Evans Beatson Institute for Cancer Research - Glasgow
  More Information Identifier: NCT00003679     History of Changes
Other Study ID Numbers: CDR0000066780
Study First Received: November 1, 1999
Last Updated: November 5, 2013

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIB breast cancer
inflammatory breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents processed this record on April 25, 2017