Trial Information

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

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.