NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
ConditionBreast Cancer Invasive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan Cancer Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age>=18 years old
cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
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)；
Disqualifiers
The patient has evidence of metastatic breast cancer；
For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
The patient has a second primary malignancy other than adequately treated skin cancer;
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；
Trial design
Treatments tested in this trial
- Serplulimab
- NabPE
Treatment groups
709 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov