Recruiting
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). 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…
ClinicalTrials.gov IDNCT06781281
PhaseNot Applicable
Enrollment709
SponsorHenan Cancer Hospital
Age18 Years and older
SexALL
About this study
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). 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 begining of the treatment.
Interventions
- Drug: Serplulimab — Serplulimab
- Drug: NabPE — Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2
Primary outcomes
- pathological complete response (24 weeks)
Eligibility information
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.
Study locations
- Henan cancer hospital, Zhengzhou, China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.