Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients

Sponsor
Istituto Oncologico Veneto IRCCS
Study ID
NCT04659551
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epirubicin — DRUG
    Epirubicin 90 mg/mq i.v. every 3 weeks for three cycles
  • Cyclophosphamide — DRUG
    Cyclophosphamid 600 mg/mq i.v. every 3 weeks for three cycles
  • Triptorelin — DRUG
    Triptorelin 3.75 mg i.m. every 4 weeks until surgery
  • Exemestane — DRUG
    Exemestane 25 mg oral continuous daily dose until surgery
  • Nivolumab — DRUG
    Nivolumab 240 mg flat dose i.v. every two weeks for 8 cycles

Study Details

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.

Key Dates

Start date
Oct 5, 2017
Status verified
Dec 2020
Primary completion
May 25, 2020
Completion
May 25, 2020

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Epirubicin 90 mg/mq + Cyclophosphamide 600 mg/mq i.v. every 3 weeks for 3 courses, followed by Nivolumab (240 mg flat dose i.v. each 2 weeks) for 8 courses plus exemestane 25 mg (orally, continuous daily dose, to be continued until surgery). LHRH analogue (Triptorelin 3.75mg 1 fl i.m. every 28 days) started concomitantly to anthracycline based chemotherapy, to be continued until surgery.

Primary Outcome Measure

pathological complete response (pCR) [ Time Frame: up to 7 months from enrolment ]

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