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

Tianjin Medical University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Triple Negative Breast Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04907344

MA-BC-II-024

Details and patient eligibility

About

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).

Enrollment: 420 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 3 patient groups

Part 1: Camrelizumab + Chemotherapy

Experimental group

Treatment:

Drug: Carboplatin

Drug: Nab-Paclitaxel

Drug: Camrelizumab

Part 2: Camrelizumab + Chemotherapy

Experimental group

Treatment:

Drug: Carboplatin

Drug: Nab-Paclitaxel

Drug: Camrelizumab

Part 2: Chemotherapy

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Nab-Paclitaxel