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Combination Chemotherapy in Treating Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00003679
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2003
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: tamoxifen citrate Procedure: conventional surgery Radiation: radiation therapy Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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
Study Start Date : November 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00003679


Locations
United Kingdom
C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom, G61 1BD
Sponsors and Collaborators
Scottish Cancer Therapy Network
Investigators
Study Chair: T.R.J. Evans Beatson Institute for Cancer Research - Glasgow
More Information
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ClinicalTrials.gov Identifier: NCT00003679     History of Changes
Other Study ID Numbers: CDR0000066780
SCTN-BR9809
EU-98053
First Posted: December 5, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: May 2007

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
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Tamoxifen
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents