Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer

May 31, 2012 updated by: Northwestern University

Phase II Study of Taxotere, Doxorubicin and Cyclophosphamide (TAC) Primary Therapy in Stage III Breast Cancer

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.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, doxorubicin, and cyclophosphamide in treating women who have previously untreated stage III breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the clinical response rate to docetaxel, doxorubicin, and cyclophosphamide as primary therapy in women with stage III breast cancer. II. Determine the pathologic complete response rate to this treatment regimen in this patient population. III. Assess the side effects and toxicity profile of this treatment regimen in these patients.

OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin IV over 5-10 minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 5 weeks following completion of chemotherapy, operable patients achieving complete or partial response undergo mastectomy, segmental mastectomy, or lumpectomy with nodal dissection. Patients with positive surgical tumor margins may undergo an additional surgical procedure. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Chicago, Illinois, United States, 60603
        • Monroe Medical Associates
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed previously untreated, stage III adenocarcinoma of the breast At least one bidimensionally and/or unidimensionally measurable lesion No evidence of disease outside the breast or chest wall, except for ipsilateral axillary lymph nodes Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 5 times ULN No acute hepatitis Renal: Creatinine no greater than 1.5 mg/dL No uncontrolled hypercalcemia Cardiovascular: No congestive heart failure LVEF normal No angina pectoris No uncontrolled cardiac arrhythmias No other significant heart disease No myocardial infarction within the past year No superior vena cava syndrome No deep vein thrombosis requiring anticoagulant therapy Neurologic: No dementia No seizures No concurrent grade 2 or greater peripheral neuropathy Other: No medical instability No active infection No gastrointestinal bleeding No uncontrolled diabetes No psychological, familial, sociological, or geographical conditions or other circumstances that would preclude study No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No history of hypersensitivity to polysorbate 80 Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: No prior hormonal therapy for breast cancer No concurrent corticosteroids except for chronic methylprednisolone or equivalent for more than 6 months duration at no more than 20 mg/day Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

March 2, 2004

First Posted (Estimate)

March 3, 2004

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 98B1
  • NU-98B1
  • NCI-G99-1643

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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