- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635487
A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
March 18, 2023 updated by: Caigang Liu, Shengjing Hospital
A Single-arm, Phase II Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
This is a single-arm, phase II trial evaluating the efficacy and safety of SHR-A1811 combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer.
Subjects will receive the neoadjuvant therapy of SHR-A1811 and 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 (Anticipated)
61
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
- Name: Nan Niu, MD
- Phone Number: 86-18940256668
- Email: niunannancy@163.com
Study Locations
-
-
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
Genders Eligible for Study
Female
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-A1811+Pyrotinib
|
SHR-A1811
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
Collaborators
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 (Anticipated)
February 28, 2024
Study Completion (Anticipated)
February 28, 2029
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)
March 21, 2023
Last Update Submitted That Met QC Criteria
March 18, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
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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