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Trial Title:
Serplulimab Plus Chemotherapy for Early-stage ER+/HER2- Breast Cancer
NCT ID:
NCT06394661
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HR+ breast cancer
neoadjuvant
serplulimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Serplulimab plus neoadjuvant nab-PE. Specific medication measures: Epirubicin 75mg/m2
ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serulizumab 4.5mg/Kg ivgtt on
Day 3）every 3 weeks for 6 cycles.
Arm group label:
Serplulimab group
Other name:
NabPE+Sluritumab
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 3 cycles.
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 navulizumab 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age>=18 years old
2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and
pathologically；
3. Pathologically proven HR+/HER2- breast cancer:
defined as:
- positive for ER or PR (IHC nuclear staining >1%)
- Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by
FISH)；
4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or
MR (optional) within 1 month before randomization；
5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no
contraindications to chemotherapy；
6. Cardiac ultrasound EF value ≧55%；
7. Females of childbearing age, with a negative serum pregnancy test 14 days before
randomization;
8. ECOG score≤1 point;
9. Sign informed consent；
Exclusion Criteria:
1. The patient has evidence of metastatic breast cancer；
2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation
therapy, etc. have been received;
3. The patient has a second primary malignancy other than adequately treated skin
cancer;
4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1),
anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other
immunotherapy；
5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
6. The patient has severe lung or heart disease;
7. The patient has active hepatitis B and C;
8. The patient has a history of organ transplantation or bone marrow transplantation;
9. pregnant or breastfeeding women;
10. The investigators considered chemotherapy contraindicated due to serious,
uncontrolled other medical conditions.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan cacer hospital
Address:
City:
Henan
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu Zhen
Phone:
13838308034
Start date:
April 28, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06394661
