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

December 2, 2024 updated by: Caigang Liu, Shengjing Hospital

A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
        • Principal Investigator:
          • Caigang Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged ≥ 18 but ≤ 75 years
  2. Histologically confirmed to be HR+/HER2-Low invasive breast cancer
  3. Treatment-naive patients with stage II-III
  4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
  5. Good level of organ function
  6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits

Exclusion Criteria:

  1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
  2. Received any other anti-tumor therapy at the same time
  3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
  4. Stage IV breast cancer
  5. Not confirmed by histopathology
  6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
  7. Participated in other drug clinical trials within 4 weeks before enrollment
  8. Known allergic history of the drug components of this protocol
  9. History of immunodeficiency
  10. Clinically significant cardiovascular diseases
  11. Known or suspected interstitial lung disease
  12. Active hepatitis and liver cirrhosis
  13. Known hereditary or acquired bleeding thrombotic tendency
  14. History of neurological or psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection
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
Experimental: Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection
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
Experimental: Arm 3 SHR-A1811 Injection
SHR-A1811 Injection Drug: SHR-A1811 Injection
Drug: SHR-A1811 Injection
Drug: SHR-A1811 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total pathological complete response (tpCR: ypT0-is/ypN0)
Time Frame: At the time of surgery
At the time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years
5 years
Event-free survival (EFS)
Time Frame: 5 years
5 years
Disease-free survival (DFS)
Time Frame: 5 years
5 years
Breast pathological complete response (bpCR：ypT0-is)
Time Frame: At the time of surgery
At the time of surgery
Residual cancer burden (RCB)
Time Frame: At the time of surgery
At the time of surgery
Best overall response rate (BORR)
Time Frame: During 18 weeks of the neoadjuvant treatment
During 18 weeks of the neoadjuvant treatment
Health-related quality of life (HRQOL) (EORTC QLQ-C30)
Time Frame: During 18 weeks of the neoadjuvant treatment
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)
During 18 weeks of the neoadjuvant treatment
Health-related quality of life (HRQOL)
Time Frame: During 18 weeks of the neoadjuvant treatment
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL
During 18 weeks of the neoadjuvant treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Caigang Liu, MD, Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2031

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-NEO-IIT-SHR-A1811-SHR1316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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