A Phase Ⅱ Study to Evaluate Efficacy and Safety of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Triple Negative Breast Cancer
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 20
- 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
- Last Updated
- 5 years ago
Overview
Brief Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of Camrelizumab Combination With Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Investigators
Jinming Yu
Director of Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
Eligibility Criteria
Inclusion Criteria
- •Newly diagnosed breast cancer
- •18-70 Years, female;
- •life expectancy is not less than 3 months
- •Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status);
- •Stage at presentation: T1c N1-2 or T2-4 N0-2;
- •at least one measurable lesion according to RECIST 1.1;
- •Adequate function of major organs meets the following requirements:
- •Neutrophils ≥ 1.5×10\^9/L
- •Platelets ≥ 100×10\^9/L
- •Hemoglobin ≥ 90g/L
Exclusion Criteria
- •Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
- •Inflammatory breast cancer
- •patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
- •Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
- •Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
- •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
- •Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
- •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
Arms & Interventions
Camrelizumab+Chemotherapy
Participants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery
Intervention: Camrelizumab
Camrelizumab+Chemotherapy
Participants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery
Intervention: Nab paclitaxel
Camrelizumab+Chemotherapy
Participants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery
Intervention: Epirubicin
Camrelizumab+Chemotherapy
Participants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery
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 27-30 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
- Objective Overall Response Rate (ORR)(Up to approximately 25-30 weeks)
- Adverse events (AEs)(Up to approximately 35 weeks)
- 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 27-30 weeks)
- Event-Free Survival (EFS) in all participants(Up to approximately 5 years)