Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. 2-weekly for 8 courses. GnRH analogues are started concomitantly with chemotherapy and maintained until the completion of neoadjuvant treatment.
This is a multicenter, phase II neoadjuvant trial in hormone-sensitive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients will undergo a core-biopsy of the primary tumor, for the histological diagnosis and the biological characterization of the tumor. After confirmation of eligibility and informed consent signature, the patients will start neoadjuvant treatment including: Epirubicin 90 mg/mq + Cyclophosphamide 600 mg/mq i.v. every 3 weeks for 3 courses, followed by the combination of Nivolumab (240 mg flat dose i.v. each 2 weeks) for 8 courses and exemestane 25 mg (orally, continuous daily dose, to be continued until surgery). Patients will start LHRH analogue (Triptorelin 3.75mg 1 fl i.m. every 28 days) concomitantly to anthracycline-based chemotherapy, to be continued until surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Epirubicin 90 mg/mq i.v. every 3 weeks for three cycles
Cyclophosphamid 600 mg/mq i.v. every 3 weeks for three cycles
Triptorelin 3.75 mg i.m. every 4 weeks until surgery
Arcispedale S. Anna
Cona, FE, Italy
Centro di Riferimento Oncologico di Aviano (CRO)
Aviano, PN, Italy
Azienda Ospedaliera Universitaria di Parma
Parma, PR, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy
pathological complete response (pCR)
ypT0ypN0
Time frame: up to 7 months from enrolment
clinical objective response
cOR
Time frame: up to 6 months from enrolment
molecular response
Ki67
Time frame: up to 7 months from enrolment
Breast conserving surgery
Surgery type
Time frame: up to 7 months from enrolment
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events
Time frame: up to 100 days from last nivolumab dose
Correlative biomarkers
correlation between different biomarkers expression at baseline and pathological response
Time frame: Tumor samples will be collected at baseline, at 14 days after completion of anthracycline-based chemotherapy (about 7 weeks after first dose of Epirubicin), at surgery (about 30 weeks after first dose of Epirubicin)
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Exemestane 25 mg oral continuous daily dose until surgery
Nivolumab 240 mg flat dose i.v. every two weeks for 8 cycles
Istituto Oncologico veneto IRCCS
Padua, Italy