Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab
OBJECTIVES:
Primary
- To determine the percentage of pathological responses in patients with stage II or III
breast cancer treated with neoadjuvant therapy comprising fluorouracil, doxorubicin
hydrochloride, and cyclophosphamide followed by trastuzumab (Herceptin®) and
paclitaxel.
- To compare the disease-free survival of patients treated with adjuvant therapy
comprising trastuzumab versus observation.
Secondary
- To measure the overall survival at 3 years in these patients.
- To measure the cardiac safety profile of these regimens in these patients.
- To measure the percentage of patients that become negative on the fluorescence in situ
hybridization (FISH) test at the end of neoadjuvant therapy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I :
- Neoadjuvant therapy: Patients receive fluorouracil IV, doxorubicin hydrochloride
IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients
then receive trastuzumab (Herceptin®) IV over 30-90 minutes and paclitaxel IV over
1 hour once a week for 12 weeks.
After completion of neoadjuvant therapy, patients proceed to surgery.
- Surgery: Patients undergo definitive surgery. Some patients may also undergo
radiotherapy*.
NOTE: *Patients with initial tumor > 5 cm, inflammatory breast cancer, or with a skin
condition or final pathological evaluation of metastasis to > 4 nodes or 1-3 nodes with
capsular ruptures or extension to fatty tissues receive adjuvant radiotherapy.
- Adjuvant therapy: Beginning 4 weeks after surgery, patients receive trastuzumab IV over
30-90 minutes on day 1. Treatment repeats every 3 weeks for 13 courses.
- Arm II:
- Neoadjuvant therapy: Patients receive neoadjuvant therapy as in arm I.
- Surgery: Patients undergo definitive surgery. Some patients may also undergo
radiotherapy if clinically indicated.
- Observation: Beginning 4 weeks after surgery, patients undergo observation. In both
arms, patients with estrogen receptor- and/or progesterone receptor-positive disease
also receive anastrozole daily for 5 years. Premenopausal patients with remaining
ovarian function (as confirmed by follicle-stimulating hormone [FSH] and estradiol)
after completion of anastrozole undergo chemical or surgical ovarian ablation.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then once a year thereafter.
PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Percentage of pathological responses
No
Claudia Arce-Salinas, MD
Principal Investigator
Instituto Nacional de Cancerologia, Columbia
Unspecified
CDR0000557417
NCT00533936
September 2006
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