Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT04389073
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Vinorelbine 40mg — DRUG
    Two tablets per day, three times a week. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
  • Toripalimab 240mg — BIOLOGICAL
    Toripalimab 240 MG IV infusion every 3 weeks. Toripalimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
  • Bevacizumab 5 mg/kg — BIOLOGICAL
    Bevacizumab 5 mg/kg IV infusion every 3 weeks. Bevacizumab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
  • Cyclophosphamide 50 mg — DRUG
    50 mg per day. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
  • Capecitabine 500Mg Oral Tablet — DRUG
    500mg three times a day. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
  • Cisplatin — DRUG
    Cisplatin 50mg/m2 IV infusion every 3 weeks. Cisplatin will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

Study Details

The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody, JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female patients with HER2- metastatic breast cancer. The approach suggested here is to deplete and active the immune response of these patients. The combination of Toripalimab and Vinorelbine would provide a higher gain in anti-tumor response in these patients than in those with chemotherapy alone. The investigators proposal is to conduct a multicentric, single arm, Phase II trial in HER2- patients with metastatic breast cancer, aiming to evaluate the clinical activity of the combination therapy Toripalimab + metronomic Vinorelbine. Patients will receive Vinorelbine (40 mg/day, tiw, per os) and Toripalimab (240 mg every 3 weeks, intravenously \[IV\]). The adverse events of the two drugs are well known.

Key Dates

Start date
Apr 1, 2020
Status verified
Feb 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (PD-1+NVB)
    The treatments received are: * Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously \[IV\]).
  • Experimental: Arm 2 (PD-1+NVB+Bev)
    The treatments received are: * Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously \[IV\]) * Bevacizumab (5 mg/kg every 3 weeks, intravenously \[IV\]).
  • Experimental: Arm 3 (PD-1+NVB+DDP)
    * Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously \[IV\]) * Cisplatin (50mg/m2 every 3 weeks, intravenously \[IV\]).
  • Experimental: Arm 4 (PD-1+VEX)
    * Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously \[IV\]) * Cyclophosphamide (50 mg/day, qd, per os) * Capecitabine (500 mg, tid, per os)
  • Active Comparator: Arm 5 (NVB)
    • Vinorelbine (40 mg/day, tiw, per os)

Primary Outcome Measure

Clinical Benefit Rate (CBR) [ Time Frame: 6 weeks of treatment ]

Central Contacts

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