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A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer


OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with
that of epirubicin and paclitaxel in patients with metastatic breast cancer.

OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or
epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the
absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No
CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female
Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT
and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases)
Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of
cardiac disease including myocardial infarction, cardiac failure and angina Other: Not
pregnant No prior or concurrent malignancy that is likely to interfere with protocol
treatments or comparisons

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring
transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted
Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since
prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery:
Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James Carmichael, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Nottingham City Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000065426

NCT ID:

NCT00002953

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • Breast Neoplasms

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