A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs

NCT05556200 | Unknown Phase 2

• 1 other identifier: NeoCAT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) for neoadjuvant treatment of patients with triple-negative breast cancer and \>10% tumor-infiltrating lymphocytes (TILs) in baseline breast tumors. We will enroll 58 subjects (Simon's two stage design). The study is designed to evaluate the efficacy and safety of camrelizumab in combination with apatinib in the neoadjuvant treatment of TNBC with a high proportion of TILs.

Conditions

Breast Cancer; Triple-Negative Breast Cancer

Keywords

anti-PD-1 antibody; VEGFR2 TKI

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Remission (pCR) rate

  pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

  After neoadjuvant study treatment and surgery, up to approximately 24-26 weeks

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  After neoadjuvant study treatment and surgery, up to approximately 24-26 weeks

• Breast Conservation Rate

  Up to approximately 24-26 weeks

• Incidence of Treatment-Emergent Adverse Events

  From the first drug administration to within 90 days for the last dose

• Event-Free Survival (EFS)

  Up to approximately 8 years

• Overall Survival (OS)

  Up to approximately 8 years

Study Arms (1)

Experiment

EXPERIMENTAL

Eligible patients enrolled receive camrelizumab 200 mg, iv, d1, every 21 days (3 mg/kg if weight \<50 kg) in combination with apatinib 250 mg, po, qd for neoadjuvant treatment for 8 cycles. Patients evaluated after neoadjuvant therapy with pCR receive 9 cycles of postoperative adjuvant camrelizumab (200 mg, iv, or 3 mg/kg if weight \<50 kg, d1,q3W) + apatinib (250 mg, po, qd). Patients with non-pCR after neoadjuvant therapy receive adjuvant chemotherapy of the physician's choice (TPC).

Drug: Anti-PD-1 monoclonal antibody; Drug: VEGFR2 Tyrosine Kinase Inhibitor

Interventions

Anti-PD-1 monoclonal antibody DRUG

Camrelizumab 200 mg, iv, d1, q3W (3 mg/kg if weight \<50 kg)

Also known as: Camrelizumab

Experiment

VEGFR2 Tyrosine Kinase Inhibitor DRUG

Apatinib 250 mg, po, qd

Also known as: Apatinib

Experiment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients sign the written informed consent.
• Women aged 18-70.
• Patients with histologically confirmed operable invasive breast cancer (T1cN1-2 or T2-4N0-2)［ER-negative(IHC\<1%), PR-negative(IHC\<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
• Percentage of tumor-infiltrating lymphocytes \>10% in baseline breast tumor.
• Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
• No previous breast cancer-related treatment, including chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy.
• Patients can swallow pills.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Patients with a life expectancy of at least 12 weeks.
• The patient's blood test results prior to enrollment met the following criteria： • Hb≥90g/L; • Plt≥100\^9/L; • Serum albumin ≥3g/dL; • Neutrophils≥1.5\^9/L;
• TSH≤ normal upper limit (ULN);
• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);
• TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);
• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);
• AKP≤ 2.5 ULN;

You may not qualify if:

• Combination of other malignancies or previous malignancies other than breast cancer within the last 5 years, except for basal cell carcinoma or flat cell carcinoma of the skin or carcinoma in situ of the uterine cervix that has been adequately controlled by treatment.
• Those who are not suitable for immunotherapy in combination with active infection.
• The combination of severe non-malignant disease that would affect patient compliance or put the patient at risk.
• Concomitant with other antineoplastic therapy or are participating in other clinical trials.
• Male breast cancer, bilateral breast cancer or inflammatory breast cancer.
• Patients with dementia, mental abnormality or any mental illness that prevents understanding of the informed consent form.
• Patients with history of allergic reaction or contraindication to the use of any drug component of this trial.
• Patients with any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose asthma has completely resolved in childhood and does not require any intervention in adulthood may be included; (Patients with asthma that requires medical intervention with bronchodilators cannot be included).
• Have cardiac clinical symptoms or disease that are not well controlled, such as:
• (1) NYHA class 2 or higher heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• \. Urine routine suggestive of urine protein ≥++, or confirmed 24-hour urine protein amount ≥1.0g.
• \. Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
• \. Patients with congenital or acquired immune deficiencies (e.g., HIV-infected individuals).
• \. Live vaccines administered less than 4 weeks prior to study drug administration or possibly during the study.
• \. Active tuberculosis. 15. Patients have received oral or intravenous antibiotic therapy within 2 weeks prior to neoadjuvant therapy.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (4)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

Shanwei, Guangdong, 516600, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

spartalizumab; camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jieqiong Liu, M.D., Ph.D.

  Sun Yet-sen Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieqiong Liu, MD,PhD

CONTACT

020-34071156; liujieqiong01@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 27, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (4)