HERA: A Randomised Three-Arm Multi-Centre Comparison Of 1 Year And 2 Years Of Herceptin Versus No Herceptin In Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
- Compare the disease-free survival of women with HER2-positive primary breast cancer
treated with trastuzumab (Herceptin®) for 1 year vs trastuzumab for 2 years vs standard
- Compare the overall survival of patients treated with these regimens.
- Compare the relapse-free survival of patients treated with these regimens.
- Compare the distant disease-free survival of patients treated with these regimens.
- Compare the incidence of cardiac dysfunction in patients treated with these regimens.
- Evaluate the safety and tolerability of these regimens in these patients.
- Compare time to recurrence in patients treated with these regimens.
- Compare time to distant recurrence in patients treated with these regimens.
- Compare outcomes, in terms of disease-free survival, overall survival, recurrence-free
survival, distant disease-free survival, time to recurrence, time to distant
recurrence, cardiac safety, and overall safety, in patients treated with trastuzumab
for 1 year vs 2 years.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no
positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior
neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy),
prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs
anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and
no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to
49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3
- Arm I: Patients receive trastuzumab (Herceptin®) IV over 1.5 hours on day 1. Courses
repeat every 3 weeks for up to 1 year in the absence of disease progression or
- Arm II: Patients receive trastuzumab as in arm I. Courses repeat every 3 weeks for up
to 2 years in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive no trastuzumab. Patients may later receive trastuzumab as in
arm I or arm II.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: Approximately 4,482 patients (1,494 per treatment arm) will be accrued
for this study within 4 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Martine J. Piccart-Gebhart, MD, PhD
Institut Jules Bordet
Sweden: Swedish Medical Products Agency