NCT07317778

Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer

Chemotherapy Combine With or Without Adebrelimab and Trastuzumab Rezetecan(SHR-A1811) as Neoadjuvant Therapy for Hormone Receptor Positive/HER2 Low Early Stage Breast Cancer: A Randomized Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 249 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are: Is Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+/HER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and/or Adebrelimab plus chemotherapy Participants will: Take 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1). Visit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.

Conditions

• Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• HR Positive/HER2 Low Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811	An anti-HER2 ADC injection, administered on day 1 of each cycle, with one cycle every 3 weeks. 4.8mg/kg or 5.6mg/kg IV, according to the outcomes of the safety run in process.
DRUG	Adebrelimab (PD-L1 inhibitor)	A PD-L1 inhibitor, 1200mg IV, is administered on the 1st day of every 3 weeks cycle.
DRUG	Taxane Chemotherapy	Could be paclitaxel, docetaxel or Nab-paclitaxel, according to physician's choice.
DRUG	Anthracycline & Cyclophosphamide treatment scheme	Anthracycline usually use epirubicin, 90-100mg/m2, combine with Cyclophosphamide 600mg/m2, both use at day 1, every 3 weeks cycle.

Timeline

• Start date: 2026-02-15
• Primary completion: 2028-10-15
• Completion: 2033-09-15
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: China