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S0012 Doxorubicin, Cyclophosp...

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

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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OBJECTIVES:

* Compare the microscopic pathologic response rates in women with inflammatory or locally advanced breast cancer treated with standard neoadjuvant doxorubicin and cyclophosphamide followed by weekly paclitaxel vs weekly doxorubicin and daily oral cyclophosphamide with filgrastim (G-CSF) followed by weekly paclitaxel.
* Compare the toxic effects of these regimens in this patient population.
* Compare the delivered dose intensity of these regimens in this patient population.
* Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (inflammatory vs other). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive doxorubicin IV followed by cyclophosphamide IV on day 1. Treatment repeats every 21 days for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Three weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour weekly on day 1 for a total of 12 weeks.
* Arm II: Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and filgrastim (G-CSF) subcutaneously on days 2-7. Treatment repeats weekly for a total of 15 courses of doxorubicin and cyclophosphamide and 16 courses of G-CSF in the absence of disease progression or unacceptable toxicity. One week after completion of G-CSF, patients receive paclitaxel as in arm I.

Within 3-6 weeks after completion of chemotherapy, patients with stable or responsive disease undergo surgical resection of tumor and affected nodes.

After surgery, patients may receive radiotherapy or additional chemotherapy and/or hormonal therapy at the discretion of the treating physician.

Patients are followed every 6 months for 1 year and then annually for 4 years.

PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this study within 3 years.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AC followed by P

doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery

Group Type ACTIVE_COMPARATOR

cyclophosphamide

Intervention Type DRUG

doxorubicin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

surgery

Intervention Type PROCEDURE

AC+G followed by P

weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

doxorubicin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

surgery

Intervention Type PROCEDURE

Interventions

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filgrastim

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

doxorubicin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

surgery

Intervention Type PROCEDURE

Other Intervention Names

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G-CSF cytoxan Adriamycin

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georgiana K. Ellis, MD

Role: STUDY_CHAIR

Seattle Cancer Care Alliance

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Highlands Oncology Group - Springdale

Springdale, Arkansas, United States

Site Status

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, United States

Site Status

Saint Rose Hospital

Hayward, California, United States

Site Status

Valley Memorial Hospital

Livermore, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Highland General Hospital at St. George's University School of Medicine

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Summit Medical Center

Oakland, California, United States

Site Status

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, United States

Site Status

J.C. Robinson, M.D. Regional Cancer Center

San Pablo, California, United States

Site Status

Memorial Hospital Cancer Center

Colorado Springs, Colorado, United States

Site Status

Halifax Medical Center

Daytona Beach, Florida, United States

Site Status

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status