Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCI SWOG-S0012 S0012, NCT00016406

Special Category: CTSU trial

Objectives

1. 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 cyclphosphamide with filgrastim (G-CSF) followed by weekly paclitaxel.
2. Compare the toxic effects of these regimens in this patient population.
3. Compare the delivered dose intensity of these regimens in this patient population.
4. Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Comparison of microscopic pathologic response rates
Toxicity
Comparison of delivered dose intensity
Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site

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.

Slovak ML, Bedell V, Lew D, et al.: Screening for clonal hematopoiesis as a predictive marker for development of t-AML following adjuvant therapy for breast cancer (S0012). [Abstract] J Clin Oncol 25 (Suppl 18): A-11051, 2007.

Ellis GK, Green SJ, Russell CA, et al.: SWOG 0012, a randomized phase III comparison of standard doxorubicin (A) and cyclophosphamide (C) followed by weekly paclitaxel (T) versus weekly doxorubicin and daily oral cyclophosphamide plus G-CSF (G) followed by weekly paclitaxel as neoadjuvant therapy for inflammatory and locally advanced breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA537, 2006.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Georgiana Ellis, MD, Protocol chair		Ph: 206-288-7222

Registry Information
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
Trial Start Date		2001-05-01
Registered in ClinicalTrials.gov		NCT00016406
Date Submitted to PDQ		2001-03-29
Information Last Verified		2005-12-05
NCI Grant/Contract Number		CA32102

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