A Single-arm, Prospective Phase II Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Triple Negative Breast Cancer
- Sponsor
- West China Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
Shuangyue Liu
Clinical Professor
West China Hospital
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-
- •life expectancy is not less than 3 months.
- •at least one measurable lesion according to RECIST 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.
Arms & Interventions
Camrelizumab + Apatinib + Chemotherapy
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).
Intervention: Camrelizumab
Camrelizumab + Apatinib + Chemotherapy
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).
Intervention: Apatinib
Camrelizumab + Apatinib + Chemotherapy
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).
Intervention: Nab-paclitaxel
Camrelizumab + Apatinib + Chemotherapy
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).
Intervention: Epirubicin
Camrelizumab + Apatinib + Chemotherapy
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).
Intervention: Cyclophosphamide
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- 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)