Study of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

NCT04907344 | Unknown Phase 2

• 1 other identifier: MA-BC-II-024
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

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).

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Up to approximately 24 weeks

Secondary Outcomes (6)

• 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

• Objective Response Rate (ORR)

  Up to approximately 24 weeks

• Event-Free Survival (EFS)

  Up to approximately 5 years

• Invasive Disease-Free Survival (iDFS)

  Up to approximately 5 years

• Overall survival (OS)

  Up to approximately 5 years

Study Arms (3)

Part 1: Camrelizumab + Chemotherapy

EXPERIMENTAL

Drug: Camrelizumab; Drug: Nab-Paclitaxel; Drug: Carboplatin

Part 2: Camrelizumab + Chemotherapy

EXPERIMENTAL

Drug: Camrelizumab; Drug: Nab-Paclitaxel; Drug: Carboplatin

Part 2: Chemotherapy

ACTIVE COMPARATOR

Drug: Nab-Paclitaxel; Drug: Carboplatin

Interventions

Camrelizumab DRUG

IV infusion

Part 1: Camrelizumab + Chemotherapy; Part 2: Camrelizumab + Chemotherapy

Nab-Paclitaxel DRUG

IV infusion

Part 1: Camrelizumab + Chemotherapy; Part 2: Camrelizumab + Chemotherapy; Part 2: Chemotherapy

Carboplatin DRUG

IV infusion

Part 1: Camrelizumab + Chemotherapy; Part 2: Camrelizumab + Chemotherapy; Part 2: Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed breast cancer;
• 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.

You may not qualify if:

• 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);
• Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis;
• Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia;
• Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment;
• Has evidence of active tuberculosis within 1year prior to initiation of study treatment;
• Prior allogeneic stem cell or solid organ transplantation;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Breast Cancer Department I, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Breast Oncology, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Zhongsheng Tong, MD

  Breast Oncology, Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Xuchen Cao, MD

  Breast Cancer Department I, Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongsheng Tong, MD

CONTACT

+8618622221181; 18622221181@163.com

Xuchen Cao, MD

CONTACT

+8618622221160; caoxuchen@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Oncology

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: June 15, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

CN (2)