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Recruiting NCT05447702

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

Phase II Interventional Triple Negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab, Apatinib, Nab-paclitaxel, Epirubicin.
Who it may be relevant to
Registry conditions: Triple Negative Breast Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)

Overview

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).

Interventions

  • Drug Camrelizumab
    Intravenous (IV) infusion
  • Drug Apatinib
    po.
  • Drug Nab-paclitaxel
    IV infusion.
  • Drug Epirubicin
    IV infusion.
  • Drug Cyclophosphamide
    IV infusion.

Primary outcome measures

  • 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 [Time frame: Up to approximately 28 weeks]
Secondary outcome measures (5)
  • 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 [Time frame: Up to approximately 28 weeks]
  • Objective Response Rate (ORR) [Time frame: Up to approximately 28 weeks]
  • Event-Free Survival (EFS) [Time frame: Up to approximately 3 years]
  • Invasive Disease-Free Survival (iDFS) [Time frame: Up to approximately 3 years]
  • Adverse events (AEs) [Time frame: Up to approximately 37 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Publications

  • Liu X, Zhuang C, Liu L, Xiong L, Xie X, He P, Li J, Wei B, Yan X, Tian T, Zhong X, Chen J, Cheng Y, Zheng D, Cheng P, Sun T, Li W, Zhu C, Chen S, Fang C, Fu J, Li S, Jing J, Luo T. Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and PMID 40691458

Identifiers

NCT: NCT05447702 · MA-BC-II-026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗