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

NCT05447702 | Recruiting Phase 2

• 1 other identifier: MA-BC-II-026
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

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

  Up to approximately 28 weeks

Secondary Outcomes (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

  Up to approximately 28 weeks

• Objective Response Rate (ORR)

  Up to approximately 28 weeks

• Event-Free Survival (EFS)

  Up to approximately 3 years

• Invasive Disease-Free Survival (iDFS)

  Up to approximately 3 years

• Adverse events (AEs)

  Up to approximately 37 weeks

Study Arms (1)

Camrelizumab + Apatinib + Chemotherapy

EXPERIMENTAL

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).

Drug: Camrelizumab; Drug: Apatinib; Drug: Nab-paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

Interventions

Camrelizumab DRUG

Intravenous (IV) infusion

Camrelizumab + Apatinib + Chemotherapy

Apatinib DRUG

po.

Camrelizumab + Apatinib + Chemotherapy

Nab-paclitaxel DRUG

IV infusion.

Camrelizumab + Apatinib + Chemotherapy

Epirubicin DRUG

IV infusion.

Camrelizumab + Apatinib + Chemotherapy

Cyclophosphamide DRUG

IV infusion.

Camrelizumab + Apatinib + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed breast cancer.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; apatinib; 130-nm albumin-bound paclitaxel; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Ting Luo, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Luo, MD

CONTACT

+86 18602866299; tina621@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: Clinical Professor

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 7, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

CN (1)