Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Drug: Serplulimab+NabPE
- Registration Number
- NCT06394661
- Lead Sponsor
- Henan Cancer Hospital
- Brief Summary
The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab. The main questions it aims to answer are:
Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature.
Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the beginning of the treatment.
- Detailed Description
In recent years, significant progress has been made in the immunotherapy of breast cancer, and PD1/PDL1 inhibitors have achieved good results in the treatment of triple-negative breast cancer. There have also been many attempts to apply them in HR+/HER2- breast cancer. In the I-SPY2 study, Pembrolizumab combined with chemotherapy increased the pCR rate of HR+/HER2- breast cancer from 13% in the chemotherapy alone group to 30%. In the KEYNOTE756 study, Pembrolizumab in combination with chemotherapy increased the pCR rate by 8.5% (24.3% vs. 15.6%) compared to the chemotherapy-only arm in HR+/HER2- breast cancer. pCR rates in the Nivolumab arm of the CheckMate 7FL study were 24.5% compared with 13.8% in the control arm. While further long-term follow-up data are still needed to confirm patient benefit, it still provides a new treatment option for HR+/HER2- breast cancer patients.
The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.
The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 109
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Serplulimab group Serplulimab+NabPE NabPE+Serplulimab group（Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3）every 3 weeks for 6 cycles. Then paticipants will receive surgery and Serplulimab will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.
- Primary Outcome Measures
Name Time Method pathological complete response up to 24 weeks After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
- Secondary Outcome Measures
Name Time Method Event-Free Survival (EFS) 5-10 years EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause.
DFS 5-10 years Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Objective Response Rate (ORR) up to 24 weeks ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
adverse events After each cycle of chemotherapy (21 days as 1 cycle)] Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Trial Locations
- Locations (1)
Henan cacer hospital
🇨🇳Henan, Henan, China