A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

July 3, 2024 updated by: Caigang Liu, Shengjing Hospital

A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib 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)

65

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:
          • Nan Niu, MD
        • Principal Investigator:
          • Cai-Gang 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged ≥ 18 but ≤ 75 years
  • Histologically confirmed to be HER2-positive invasive breast cancer
  • Treatment-naive patients with stage II-III
  • Eastern Cooperative Oncology Group (ECOG) score 0-1
  • Good level of organ function

Exclusion Criteria:

  • Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
  • Received any other anti-tumor therapy at the same time
  • Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
  • Stage IV breast cancer
  • With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
  • Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
  • Participated in other drug clinical trials within 4 weeks before enrollment
  • History of allergies to the drug components of this protocol
  • Clinically significant pulmonary diseases
  • Clinically significant cardiovascular diseases
  • History of immunodeficiency
  • Active hepatitis and liver cirrhosis

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: SHR-A1811
Drug: SHR-A1811
SHR-A1811
Experimental: SHR-A1811+Pyrotinib
Drug: SHR-A1811
SHR-A1811
Drug: Pyrotinib
Pyrotinib

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)

March 16, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2030

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUKDEN 07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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