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Combination Chemotherapy in Treating Women With Breast Cancer

NCT ID: NCT00003679

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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stage IIIA breast cancer stage IIIB breast cancer inflammatory breast cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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cyclophosphamide

Intervention Type DRUG

docetaxel

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

tamoxifen citrate

Intervention Type DRUG

conventional surgery

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Scottish Cancer Therapy Network

OTHER

Sponsor Role lead

Principal Investigators

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T.R.J. Evans

Role: STUDY_CHAIR

Beatson Institute for Cancer Research - Glasgow

Locations

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C.R.C. Beatson Laboratories

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SCTN-BR9809

Identifier Type: -

Identifier Source: secondary_id

EU-98053

Identifier Type: -

Identifier Source: secondary_id

CDR0000066780

Identifier Type: -

Identifier Source: org_study_id