Persephone: Duration of Trastuzumab With Chemotherapy in Women With Early Stage Breast Cancer: Six Months Versus Twelve
- Determine disease-free survival of women with HER2-positive early breast cancer treated
with neoadjuvant or adjuvant trastuzumab (Herceptin®) for 6 months versus 12 months.
- Determine the overall survival of patients treated with these regimens.
- Determine the expected incremental cost effectiveness (cost per quality adjusted life
year gained) for 6 months versus 12 months trastuzumab.
- Determine cardiac function as assessed by left ventricular ejection fraction every 3
months during treatment.
- Analyze the predictive factors for development of cardiac damage.
OUTLINE: This is a multicenter study. Patients are stratified according to estrogen receptor
status (negative vs positive); chemotherapy timing (adjuvant vs neoadjuvant); chemotherapy
type (anthracycline based [no taxane] vs taxane and anthracyclines vs taxane-based [no
anthracyclines]); and trastuzumab (Herceptin®) timing (concurrently vs sequentially [with
respect to chemotherapy]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 12 months in the absence of disease progression or unacceptable
- Arm II: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 6 months in the absence of disease progression or unacceptable
All patients also receive standard chemotherapy regimens as per local institutional
protocols either concurrently with or sequentially to trastuzumab.
Patients complete quality of life questionnaires using the EuroQoL-5D (EQ-5D) at baseline
and periodically during study treatment. Patients also complete a diary on out-of-pocket
expenses associated with their condition (i.e., travel expenses, over-the-counter medicines
and supplements, complementary therapies not funded by NHS, home help, and time away from
work) for cost-effective analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, then
every 6 months for 1 year, and annually thereafter.
Allocation: Randomized, Primary Purpose: Treatment
Helena Earl, MBBS, PhD, FRCP
Cambridge University Hospitals NHS Foundation Trust