Efficacy and Safety of Combinition of Camrelizumab in Second-line Neoadjuvant Chemotherapy and Adjuvant Therapy

Sponsor
Peking University First Hospital
Study ID
NCT04848454
Phase
PHASE2
Status
Unknown

Conditions

  • Cisplatin
  • HER2-negative Breast Cancer
  • Immunotherapy
  • Neoadjuvant Therapy
  • Pathological Complete Response
  • Vinorelbine

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab with vinorelbine and cisplatin — DRUG
    Camrelizumab: 200mg iv., every 3 weeks(one cycle), for 1 year(17cycles in total); Vinorelbine: 25mg/m2 day 1, 8 iv. or 60-80 mg/m2 or. day1, 8, every 3 weeks(one cycle), for 6 cycles; Cisplatin: 75mg/m2 (divided into 2 days), every 3 weeks(onr cycle), for 6 cycles.

Study Details

The achievement of pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) is associated with improved outcome across all breast cancer (BC) subtypes. Anthracycline and taxanes based chemotherapy is usually the first choice of NACT for human epidermal growth factor receptor 2 (HER2) negative breast cancer, but there is no ideal second-line therapy for those with unsatisfactory effect after first-line NACT. Vinorelbine combined with cisplatin may be a choice for patients after failure or progression with anthracycline and/or taxanes. Immunotherapy has achieved good efficacy in many malignant tumors. Chemotherapy may have a certain immune activation effect, thus combination of immunotherapy and chemotherapy has significant clinical value in neoadjuvant and adjuvant treatment of breast cancer. So we designed this one center single arm phase 2 clinical trial to test the efficacy and safety of camrelizumab (PD-1 inhibitor) combined with vinorelbine and cisplatin as a second-line therapy for HER2 negative breast cancer patients who did not achieve significant effect after 2 cycle treatments of anthracycline plus taxanes NACT. The target population of our study are early-stage HER2 negative breast cancer patients with indications of NACT who did not receive partial response after 2 cycle of standard anthracycline and taxanes treaments according to RECIST 1.1 criteria. The enrolled patients will receive 6 cycles of camrelizumab combined with vinorelbine and cisplatin as second-line neoadjuvant therapy. Then they need to undergo surgery. The subjects have to continue camrelizumab until it is totally used for 1 year (about 17 cycles in all). The patients will routinely receive conventional adjuvant therapy and enter the long-term follow-up to get their survival infoumation.

Key Dates

Start date
Nov 20, 2021
Status verified
Oct 2022
Primary completion
Feb 28, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Drug: Vinorelbine i.v. 25 mg/m2, d1, d8 or p.o. 60-80 mg/m2 d1, d8; q3w; for 6 cycles. Cisplatin i.v. 75 mg/m2，d1, d2; q3w; for 6 cycles. Camrelizumab i.v. 200mg, q3w; for 17cycles (1 year).

Primary Outcome Measure

Pathological complete response (pCR) [ Time Frame: 1 month after the definitive surgery (if the patient does receive the surgery, usually 3-4 weeks after the last cycle of neoajuvant therapy) ]

Central Contacts

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