PROTOCOL ID: NSABP B-27

PROJECTED ACCRUAL: Approximately 2,411 patients were accrued.

OBJECTIVES

1. Compare overall and disease-free survival in patients with operable breast cancer treated with four courses of preoperative AC alone versus four courses of preoperative or postoperative docetaxel following four courses of preoperative AC .
2. Evaluate whether the addition of pre operative docetaxel to preoperative AC results in improved rates of clinical and pathologic locoregional tumor response .
3. Assess whether the addition of pre operative docetaxel to properative AC results in improved rates of breast conservation .
4. Assess whether postoperative docetaxel improves disease-free and overall survival in patients who receive preoperative AC, especially in certain subgroups of patients (e.g., those with pathologically positive nodes).

PARTICIPATION CRITERIA

• Any age, with life expectancy of >=10 years exclusive of cancer diagnosis
• Histologically or cytologically proven invasive breast cancer
• <= 63 days between diagnosis and randomization
• Tumor palpable on clinical exam and confined to the breast and ipsilateral axilla
• If clinically negative axillary nodes (N0): primary tumor greater than 1 cm (T1c-T3)
• If clinically positive axillary nodes (N1): any size primary tumor (T1-3)
• No N2 disease
• ER/PR-positive or negative

STUDY CONTACT

Norman Wolmark, Chair, Ph: 412-359-3336 National Surgical Adjuvant Breast and Bowel Project Allegheny General Hospital, Pennsylvania

PROTOCOL IDS: SWOG-S0012, CTSU

PROJECTED ACCRUAL: A total of 300 patients (150 per arm) will be accrued for this study.

OBJECTIVES

1. Compare the response rates in women with inflammatory or estrogen receptor-negative, locally advanced breast cancer treated with neoadjuvant doxorubicin and cyclophosphamide with vs without filgrastim (G-CSF).
2. Compare the toxic effects of these regimens.
3. Compare the delivered dose intensity of these regimens.
4. Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.

PARTICIPATION CRITERIA

• Age and menopausal status not specified
• 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
• Estrogen receptor-negative if disease is not inflammatory

STUDY CONTACT

Georgiana Kehr Ellis, Chair, Ph: 206-288-2048 Southwest Oncology Group

PROTOCOL ID: EORTC-10994

PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 3 years.

OBJECTIVES

1. Compare neoadjuvant fluorouracil, epirubicin and cyclophosphamide vs docetaxel and epirubicin followed by radiotherapy and surgery in women with locally advanced, inflammatory or large operable breast cancer.
2. Compare the progression-free survival with these regimens.
3. Compare the distant metastasis-free survival and survival of patients treated with these regimens.
4. Compare clinical and pathological responses to these regimens.
5. Compare the toxicity of these regimens in these patients.

PARTICIPATION CRITERIA

• Age 70 and under
• Histologically confirmed breast cancer
• Locally advanced or inflammatory disease (T4a-d, any N, M0; or any T, N2 or N3, M0)
• Large T2 or T3 breast cancer requiring tumor shrinkage prior to BCT

STUDY CONTACTS

Herve Bonnefoi, Chair, Ph: 011-41-22-382-33-11 EORTC Breast Cancer Group

Jonas Bergh, Chair, Ph: 46-8-51776279 Swedish Breast Cancer Group

Barbara Muster, Chair Ph: 011-41-31-389-9191 Swiss Institute for Applied Cancer Research

PROTOCOL IDS: GOCS-08-BR-95-III, NCI-F95-0036

PROJECTED ACCRUAL: If unacceptable toxicity is observed in 10 or more patients, the study will be closed.

OBJECTIVES

1. Compare the response to neoadjuvant therapy with fluorouracil, doxorubicin and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate and fluorouracil (CMF) in patients with stage III breast cancer.
2. Compare the rate of breast conservation and local-regional control with these two regimens.
3. Assess the disease-free and overall survival.
4. Assess the toxic effects, cosmetic results after conservative surgery, quality of life and patient compliance.

PARTICIPATION CRITERIA

• Breast cancer histologically confirmed by tru-cut needle biopsy
• Measurable, stage III (UICC staging system) disease
• No inflammatory breast cancer

STUDY CONTACT

Bernardo A. Leone, Chair, Ph: 54-299-4485247 Grupo Oncologico Cooperativo del Sur

STUDY CONTACT
Ian Smith, MD, Chair
Royal Marsden Hospital
London, United Kingdom

STUDY CONTACT
Aman Buzdar, MD
MD Anderson Cancer Center
Houston, Texas