Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]
- Compare the disease-free survival of women with nonmetastatic, resectable breast cancer
treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months.
- Compare cardiotoxicity in patients receiving these regimens.
- Compare the cardiotoxicity and disease-free survival of patients receiving concurrent
trastuzumab and chemotherapy vs sequential administration.
- Correlate HER-2 polymorphism with disease-free survival/cardiotoxicity in these
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to participating center, modality of adjuvant chemotherapy (concurrent vs
sequential), and adjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2
- Arm I (control arm, 12-month therapy): Patients continue to receive trastuzumab
(Herceptin®) IV until a total of 12 months of therapy is completed in the absence of
disease progression or unacceptable toxicity.
- Arm II (experimental arm, 6-month therapy): Patients continue to receive trastuzumab*
IV until a total of 6 months of therapy is completed in the absence of disease
progression or unacceptable toxicity.
NOTE: *Patients who have already finished 6 months of trastuzumab at randomization do not
receive further trastuzumab.
Some patients undergo blood collection for HER-2 polymorphism analysis.
After completion of study therapy, patients are followed periodically for approximately 5
PROJECTED ACCRUAL: A total of 7,000 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Time to recurrence
Xavier Pivot, MD, PhD
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
United States: Federal Government