Overview

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

Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
West China Hospital
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Apatinib
Cyclophosphamide
Epirubicin
Paclitaxel
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.