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

NCT ID: NCT05447702

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of camrelizumab in combination with apatinib and chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC).

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab + Apatinib + Chemotherapy

Participants received neoadjuvant therapy with four 4-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and nab-paclitaxel (125 mg/m2, qw), followed by four 2-week cycles of camrelizumab (200 mg, q2w) plus apatinib (250 mg, qd) and epirubicin (90 mg/m2, q2w) + cyclophosphamide (600 mg/m2, q2w).

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

Intravenous (IV) infusion

Apatinib

Intervention Type: DRUG

po.

Nab-paclitaxel

Intervention Type: DRUG

IV infusion.

Epirubicin

Intervention Type: DRUG

IV infusion.

Cyclophosphamide

Intervention Type: DRUG

IV infusion.

Interventions

Camrelizumab

Intravenous (IV) infusion

Intervention Type: DRUG

Apatinib

po.

Intervention Type: DRUG

Nab-paclitaxel

IV infusion.

Intervention Type: DRUG

Epirubicin

IV infusion.

Intervention Type: DRUG

Cyclophosphamide

IV infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed breast cancer.
• 18-75 Years, female.
• Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
• Tumor stage: II-III.
• ECOG Performance Status of 0-1.
• life expectancy is not less than 3 months.
• 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 TAE.
• 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], and/or anti-VEGFR agent.
• 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.
• Has a history of autoimmune disease.
• Has a history of hypertension that not well controlled by antihypertensive treatment
• Has a history of myocardial infarction, severe/unstable angina pectoris, NYHA Class 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure within the last 6 months.
• 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 1 year prior to initiation of study treatment.
• Prior allogeneic stem cell or solid organ transplantation.
• Peripheral neuropathy grade ≥2.
• Has clinically significant intestinal obstruction.
• Arterial/venous thrombosis events that occurred within 3 months before enrollment, such as cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism.
• Has hemoptysis symptoms within 2 months before enrollment and the maximum daily hemoptysis ≥ 2.5 ml.
• Clinically significant bleeding symptoms or clear bleeding tendency occurred within 3 months before enrollment.
• Has known genetic or acquired bleeding or thrombotic tendency.
• Abnormal coagulation (INR>1.5 or APTT>1.5 x ULN) with bleeding tendency, receiving thrombolysis or anticoagulation therapy, or requiring long-term antiplatelet therapy.
• 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

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shuangyue Liu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Luo, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Luo, MD

Role: CONTACT

tina621@163.com

+86 18602866299

Facility Contacts

Ting Luo, MD

Role: primary

tina621@163.com

+86 18602866299

Other Identifiers

MA-BC-II-026

Identifier Type: -

Identifier Source: org_study_id