Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

Summary

RATIONALE:

1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease.
2. . It is not yet known which treatment regimen is most effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.

Conditions

• Breast Cancer

Interventions

BIOLOGICAL

epoetin alfa

40,000 IU

BIOLOGICAL

filgrastim

5 mg/kg/d - days 2-13

DRUG

cyclophosphamide

75, 600 and 830 mg/m2

DRUG

doxorubicin hydrochloride

60 mg/m2

DRUG

epirubicin hydrochloride

60 mg/m2

DRUG

fluorouracil

500mg/m2

DRUG

paclitaxel

175 mg/m2

Sponsors & Collaborators

• North Central Cancer Treatment Group

  collaborator NETWORK

• SWOG Cancer Research Network

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• NCIC Clinical Trials Group

  lead NETWORK

Principal Investigators

• Mark N. Levine, MD · Margaret and Charles Juravinski Cancer Centre

• Edith A. Perez, MD · Mayo Clinic

• Kathy S. Albain, MD · Loyola University

• Margot Burnell · Atlantic Health Sciences Corporation, Saint John NB

• Hope Rugo · Cancer and Leukemia Group B

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-12-04

Primary Completion

2014-02-10

Completion

2014-03-17

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations