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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: cyclophosphamide; Biological: filgrastim; Drug: doxorubicin; Drug: paclitaxel; Procedure: surgery

• Registration Number: NCT00016406
• Lead Sponsor: SWOG Cancer Research Network

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2001-05-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-09
• Study Completion: 2012-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 399

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC followed by P	cyclophosphamide	doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
AC followed by P	doxorubicin	doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
AC followed by P	paclitaxel	doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
AC followed by P	surgery	doxorubicin and cyclophosphamide followed by paclitaxel followed by surgery
AC+G followed by P	filgrastim	weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
AC+G followed by P	cyclophosphamide	weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
AC+G followed by P	doxorubicin	weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
AC+G followed by P	surgery	weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery
AC+G followed by P	paclitaxel	weekly doxorubicin and daily cyclophosphamide with filgrastim followed by paclitaxel followed by surgery

Primary Outcome Measures

Name	Time	Method
Comparison of microscopic pathologic response rates	no sooner than 21 days after chemo
Toxicity	during chemo and at surgery
Comparison of delivered dose intensity	after chemo
Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site	no sooner than 21 days after chemo

Trial Locations

Locations (312)

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Alaska Regional Hospital Cancer Center; 🇺🇸 Anchorage, Alaska, United States

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital; 🇺🇸 Fairbanks, Alaska, United States

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center; 🇺🇸 Ft. Smith, Arkansas, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Highlands Oncology Group - Springdale; 🇺🇸 Springdale, Arkansas, United States

Glendale Memorial Hospital Comprehensive Cancer Center; 🇺🇸 Glendale, California, United States

Saint Rose Hospital; 🇺🇸 Hayward, California, United States

Valley Memorial Hospital; 🇺🇸 Livermore, California, United States

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