Efficacy and Safety of Sintilimab and Apatinib Combined Chemotherapy in Breast Cancer

Sponsor
Jiuda Zhao
Study ID
NCT04722718
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin — DRUG
    Sintilimab:200mg,ivgtt,d1,21days/cycle;Apatinib:250mg po,d1-14days,21days/cycle;Albumin-Bound Paclitaxel(Nab-Paclitaxel):125mg/m2,ivgtt,d1,d8,21days/cycle;Carboplatin:AUC=1.5,ivgtt,d1,d8, 21days/cycle.Monitoring of blood routine, biochemical and urine routine, electrocardiogram, and record the patient's drug-related adverse reactions every cycle,according to the curative effect of patients, compliance and tolerance, neoadjuvant therapy 6 cycles,every 2 cycles to evaluate curative effect (ultrasonic, breast X-ray CT, bone scan, brain, lungs, assessment and breast MRI imaging).

Study Details

1. The efficacy and safety of immunotherapy and antiangiotherapy in combination with chemotherapy in neoadjuvant therapy for triple-negative breast cancer (TNBC) were determined by the addition of sintilimab and apatinib to neoadjuvant chemotherapy 2. To clarify the breast-conserving rate, toxicity, difference in pathologic complete response (pCR) rate of patients with PD-L1 (+) and PD-L1 (-) after neoadjuvant treatment of TNBC with immunotherapy and anti-vascular therapy combined with chemotherapy and the relationship between pCR rate of immunomodulated type (IM) and non-immunomodulated type patients in "Fudan classification". 3. Through post-treatment efficacy evaluation and safety analysis, we provide new treatment strategies for TNBC patients, increase the pCR rate of TNBC patients, and ultimately improve the long-term survival of patients.

Key Dates

Start date
Feb 1, 2021
Status verified
May 2021
Primary completion
Dec 31, 2022
Completion
Jan 31, 2023

Study Design

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

Arms

  • Experimental: Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin
    Drug:Sintilimab;Drug:Apatinib;Drug:Albumin-Bound Paclitaxel(Nab-Paclitaxel);Drug:Carboplatin

Primary Outcome Measure

pCR rate [ Time Frame: 4-6 months ]

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