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A Comparative Randomized Study of Standard Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxe

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

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 whether combination chemotherapy is more effective with or without filgrastim in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin, cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have inflammatory or locally advanced breast cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
0 and older

Gender:
Female

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed inflammatory or locally advanced breast cancer

- Stage IIB (T3, N0, M0), IIIA (T3, N1-2, M0 or T0-2, N2, M0), or IIIB (T4, any N,
M0 or any T, N3, M0)

- Unresectable or otherwise appropriate for neoadjuvant therapy

- Confirmed by core needle or incisional biopsy

- Punch biopsy allowed if invasive disease is documented

- No distant metastases

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- Not specified

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

Renal:

- Creatinine no greater than ULN

Cardiovascular:

- No congestive heart failure or angina pectoris

- LVEF greater than lower limit of normal

Other:

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- HIV negative

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for breast cancer

Endocrine therapy:

- No prior hormonal therapy for breast cancer

Radiotherapy:

- No prior radiotherapy for breast cancer

Surgery:

- No prior definitive surgery for breast cancer

Other:

- No other concurrent anticancer therapy

Gender: Female
Steward Physician(s)
  • Georgiana K. Ellis, MD
Trial Interventions
Biological
  • filgrastim
Drug
  • cyclophosphamide
  • doxorubicin
  • paclitaxel
Procedure
  • surgery
Physician Researcher

Investigator Name:

  • Georgiana K. Ellis, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00016406
Volunteers:  Not Accepting Healthy Volunteers

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