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

NCT ID: NCT04907344

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Camrelizumab + Chemotherapy

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

IV infusion

Nab-Paclitaxel

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Part 2: Camrelizumab + Chemotherapy

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

IV infusion

Nab-Paclitaxel

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Part 2: Chemotherapy

Group Type: ACTIVE_COMPARATOR

Nab-Paclitaxel

Intervention Type: DRUG

IV infusion

Carboplatin

Intervention Type: DRUG

IV infusion

Interventions

Camrelizumab

IV infusion

Intervention Type: DRUG

Nab-Paclitaxel

IV infusion

Intervention Type: DRUG

Carboplatin

IV infusion

Intervention Type: DRUG

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);
• 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;
• Pre-existing motor or sensory neuropathy of a severity≥grade 2;
• Has significant cardiovascular disease;
• Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
• Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
• History of neurological or psychiatric disorders, including epilepsy or dementia;
• Any other situation evaluated by researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhongsheng Tong

Director of Breast Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhongsheng Tong, MD

Role: PRINCIPAL_INVESTIGATOR

Breast Oncology, Tianjin Medical University Cancer Institute and Hospital

Xuchen Cao, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tianjin, Tianjin Municipality, China

Breast Oncology, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Zhongsheng Tong, MD

Role: CONTACT

Phone: +8618622221181

Email: 18622221181@163.com

Xuchen Cao, MD

Role: CONTACT

Phone: +8618622221160

Email: caoxuchen@tmu.edu.cn

Facility Contacts

Xuchen Cao, MD

Role: primary

Zhongsheng Tong, MD

Role: primary

Other Identifiers

MA-BC-II-024

Identifier Type: -

Identifier Source: org_study_id