Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer

Last updated: November 5, 2013
Sponsor: Scottish Cancer Therapy Network
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00003012
CDR0000065590
SCTN-BR9601
EU-97013
  • Female

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in treating women who have early stage breast cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Histologically confirmed, early stage, unilateral invasive breast cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node metastases OR Lymph node negative Not locally advanced If supraclavicular node is enlarged or suspicious of metastasis, negative biopsy for supraclavicular node metastases required No evidence of any other metastases clinically or on routine staging investigations No past history of pure in situ carcinoma in either breast Primary tumor is completely excised

PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Performance status: Not specified Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 No evidence of sepsis Hepatic: Adequate hepatic function Bilirubin normal AST/ALT normal Renal: Adequate renal function Creatinine less than 1.2 mg/dL Cardiovascular: No clinically significant cardiovascular disease Other: No prior or concurrent other malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior tamoxifen allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Study Design

Total Participants: 1000
Study Start date:
October 01, 1996
Estimated Completion Date:

Study Description

OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant chemotherapy in women with node positive early breast cancer, as measured by overall and event free survival from the date or randomization. II. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by quality of life.

OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.

Connect with a study center

  • University Hospitals of Leicester

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland AB25 2ZN
    United Kingdom

    Site Not Available

  • Ninewells Hospital and Medical School

    Dundee, Scotland DD1 9SY
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, Scotland EH4 9NQ
    United Kingdom

    Site Not Available

  • Beatson Oncology Centre

    Glasgow, Scotland G11 6NT
    United Kingdom

    Site Not Available

  • University of Glasgow

    Glasgow, Scotland G61 1BD
    United Kingdom

    Site Not Available

  • Raigmore Hospital

    Inverness, Scotland 1V2 3UJ
    United Kingdom

    Site Not Available

  • Royal Alexandra Hospital

    Paisley, Scotland
    United Kingdom

    Site Not Available

  • Ayr Hospital

    Ayr, KA6 6DX
    United Kingdom

    Site Not Available

  • Falkirk Royal Infirmary

    Falkirk, FK1 5RE
    United Kingdom

    Site Not Available

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