A Phase II Study of Preoperative Dose-Dense Chemotherapy With Sequential Doxorubicin and Docetaxel for Initial Treatment of Operable and Inoperable Stage II-IIIB Breast Cancer
OBJECTIVES: I. Determine the clinical and pathological response of women with stage II-IIIB
primary breast cancer to preoperative high dose chemotherapy with sequential doxorubicin and
docetaxel. II. Determine the safety and toxicity of this regimen in these patients. III.
Determine the rate of breast conservation surgery in these patients on this regimen. IV.
Determine the clinical response of these patients to docetaxel after 3 courses of
doxorubicin. V. Correlate any circulating tumor cells shed at time of surgery with clinical
response and pathological findings in these patients. VI. Determine whether tumor response
correlates with HER2/neu expression of the primary tumor.
OUTLINE: Patients receive doxorubicin IV on days 1, 15, and 29, followed by docetaxel IV
over 1 hour on days 43, 57, and 71. Filgrastim (G-CSF) is administered subcutaneously on
days 3-10 of each 2 week course. Fourteen to 21 days following preoperative chemotherapy,
patients undergo a radical, modified radical, or breast sparing surgery plus axillary lymph
node dissection. Patients with disease progression or inoperable stage IIIB disease are
removed from study. Following surgery, patients are stratified into one of three
postoperative regimens: Stratum I: Patients with 0 lymph node metastases receive no further
chemotherapy or receive cyclophosphamide, methotrexate, and fluorouracil (CMF) for 4
courses. Stratum II: Patients with 1-3 lymph node metastases receive CMF for 4 courses.
Stratum III: Patients with at least 4 lymph node metastases or stage IIIB may receive high
dose chemotherapy with stem cell support. Two to 6 weeks after surgery, patients undergoing
breast sparing procedure receive adjuvant radiotherapy. Patients undergoing mastectomy
receive chest wall and supraclavicular radiotherapy if initial clinical stage is T3, T4, or
N2. All other patients with N1 with greater than 4 lymph nodes and N3 should receive
radiotherapy. Radiotherapy is administered 5 days a week for 5.5 weeks. Patients with
positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years.
Patients are followed every 3 months for 3 years, then every 6 months for 5 years, and then
PROJECTED ACCRUAL: Approximately 27-35 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the clinical response of these patients to treatment
A clinical evaluation of tumor size includes repeat measurements of the palpable tumor in 2 dimensions, repeat mammography, if originally informative, of the affected breast with measurements of the palpable tumor in 2 or 3 dimensions and/or, evaluation of ipsilateral axillary lymph nodes with measurements, if palpable.
after 3 courses (12 weeks)
Brenda W. Cooper, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Metro Health Medical Center||Cleveland, Ohio 44109|