Clinical Trials/NCT04907344

NCT04907344

Not yet recruiting

Phase 2

A Multicenter, Open, Randomized Controlled Study of Camrelizumab+ Nab-paclitaxel + Carboplatin Versus Nab-paclitaxel + Carboplatin as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)

Tianjin Medical University Cancer Institute and Hospital2 sites in 1 country420 target enrollmentJune 15, 2021

ConditionsTriple Negative Breast Cancer

InterventionsCamrelizumab Nab-Paclitaxel Carboplatin

DrugsCamrelizumab Nab-Paclitaxel Carboplatin

Overview

Phase: Phase 2
Intervention: Camrelizumab
Conditions: Triple Negative Breast Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 420
Locations: 2
Primary Endpoint: pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in Combination With Nab-Paclitaxel and carboplatin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC).

Registry

clinicaltrials.gov

Start Date

June 15, 2021

End Date

June 30, 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Principal Investigator

Zhongsheng Tong

Director of Breast Oncology

Tianjin Medical University Cancer Institute and Hospital

Eligibility Criteria

Inclusion Criteria

•Newly diagnosed breast cancer;
•18-75 Years, female;
•ECOG Performance Status of 0-1;
•Life expectancy is not less than 3 months;
•Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status);
•Tumor stage: II-III;
•At least one measurable lesion according to RECIST 1.1;
•Adequate hematologic and organ function.;
•Must be willing to use an adequate method of contraception for the course of the study.

Exclusion Criteria

•Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer;
•Inflammatory breast cancer;
•Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and TACE;
•Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\];
•Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
•Major surgical procedure within 4 weeks prior to initiation of study treatment;
•Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus;
•Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases;
•Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study;
•Has a known history of Human Immunodeficiency Virus (HIV);

Arms & Interventions

Part 1: Camrelizumab + Chemotherapy

Intervention: Camrelizumab

Part 1: Camrelizumab + Chemotherapy

Intervention: Nab-Paclitaxel

Part 1: Camrelizumab + Chemotherapy

Intervention: Carboplatin

Part 2: Camrelizumab + Chemotherapy

Intervention: Camrelizumab

Part 2: Camrelizumab + Chemotherapy

Intervention: Nab-Paclitaxel

Part 2: Camrelizumab + Chemotherapy

Intervention: Carboplatin

Part 2: Chemotherapy

Intervention: Nab-Paclitaxel

Part 2: Chemotherapy

Intervention: Carboplatin

Outcomes

Primary Outcomes

pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery

Time Frame: Up to approximately 24 weeks

pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants.

Secondary Outcomes

Invasive Disease-Free Survival (iDFS)(Up to approximately 5 years)
Objective Response Rate (ORR)(Up to approximately 24 weeks)
Adverse events (AEs)(Up to approximately 35 weeks)
Event-Free Survival (EFS)(Up to approximately 5 years)
pCR rate using the definition of ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery(Up to approximately 24 weeks)
Overall survival (OS)(Up to approximately 5 years)