A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.

Hengrui Medicine

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Triple Negative Breast Cancer

Treatments: Drug: Carelizumab; Drug: Nab-paclitaxel; Drug: Apatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04335006

SHR-1210-III-318

Details and patient eligibility

About

This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).

Enrollment: 80 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG Performance Status of 0-1.
• Expected lifetime of not less than three months
• Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
• Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection.
• No prior systemic antitumor therapy for metastatic triple-negative breast cancer.
• Adequate hematologic and organ function
• Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

Exclusion criteria

• Known central nervous system (CNS) disease.
• Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody.
• A history of bleeding, any serious bleeding events.
• Uncontrolled pleural effusion, pericardial effusion.
• Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
• History of interstitial pneumonitis.
• Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc.
• Prior allogeneic stem cell or solid organ transplantation.
• History of autoimmune disease
• Active hepatitis B or hepatitis C
• Pregnancy or lactation.
• Peripheral neuropathy grade ≥2.
• Participants with poor blood pressure control;
• Myocardial infarction incident within 6 months prior to randomisation;
• Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
• Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Experimental A

Experimental group

Description:

Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle

Treatment:

Drug: Nab-paclitaxel

Drug: Apatinib

Drug: Carelizumab

Experimental B

Experimental group

Description:

Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle

Treatment:

Drug: Nab-paclitaxel

Drug: Carelizumab

Comparator C

Active Comparator group

Description:

Subjects receive nab-paclitaxel intravenously each 4-week cycle.

Treatment:

Drug: Nab-paclitaxel