NCT00016406

S0012 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00016406

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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 Paclitaxel As Neoadjuvant Therapy For Inflammatory and Locally Advanced Breast Cancer

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 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.

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

Disease(s) and\or Condition(s)

Breast Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: filgrastim
- Description:
- Arm Group Labels: AC+G followed by P
- Type: DRUG
- Name: cyclophosphamide
- Description:
- Arm Group Labels: AC followed by P, AC+G followed by P
- Type: DRUG
- Name: doxorubicin
- Description:
- Arm Group Labels: AC followed by P, AC+G followed by P
- Type: DRUG
- Name: paclitaxel
- Description:
- Arm Group Labels: AC followed by P, AC+G followed by P
- Type: PROCEDURE
- Name: surgery
- Description:
- Arm Group Labels: AC followed by P, AC+G followed by P

Sponsor

SWOG Cancer Research Network