Clinical trial NCT05447702: Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Official title: A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2022-07-07
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 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
timeFrame: Up to approximately 28 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to approximately 28 weeks
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 28 weeks
measure: Event-Free Survival (EFS)
timeFrame: Up to approximately 3 years
measure: Invasive Disease-Free Survival (iDFS)
timeFrame: Up to approximately 3 years
measure: Adverse events (AEs)
timeFrame: Up to approximately 37 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ting Luo, MD
role: PRINCIPAL_INVESTIGATOR
References: