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SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

NCT06340230 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-12-04

No results posted yet for this study

Summary

This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Conditions

  • HR Positive/HER2 Low Breast Cancer

Interventions

DRUG

SHR-A1811 Injection + Adebrelimab Injection

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

DRUG

SHR-A1811 Injection + Adebrelimab Injection

Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

DRUG

SHR-A1811 Injection

Drug: SHR-A1811 Injection

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Caigang Liu, MD · Shengjing Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2026-02-28
Completion
2031-02-28

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 NCT06340230 on ClinicalTrials.gov