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

NCT07317778 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2026-01-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2028-10-15
Completion
2033-09-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317778 on ClinicalTrials.gov