Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for
immunotherapy with mAb possessing ADCC/ADCP properties as trastuzumab. Combined treatment of
pegfilgrastim and trastuzumab should translate into an increased rate of pathological
clinical response. Therefore the investigators' proposal is to evaluate the clinical and
biological impact of pegfilgrastim in combination with trastuzumab + paclitaxel in
HER2-positive early stage breast cancer patients. Breastimmune02 is a multicenter,
randomized, open-label, Phase II trial. Operable HER2+ breast cancer patients previously
treated with 4 cycles of standard adriamycine/cyclophosphamide (AC) chemotherapy will be
randomized (1:1) to receive in the neoadjuvant setting:Arm A: weekly paclitaxel + trastuzumab
(every 3 weeks, Q3W) + pegfilgrastim (Q3W) versus Arm B: weekly paclitaxel + trastuzumab
(Q3W).Stratification criteria will be: cN0 versus cN1.