Back to resultsA Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Primary Purpose
HER2-positive Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-A1811
Pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer focused on measuring SHR-A1811, Pyrotinib, HER2-positive Breast Cancer, Neoadjuvant
Eligibility Criteria
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
Sites / Locations
- Shengjing Hospital affiliated to China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-A1811+Pyrotinib
Arm Description
Outcomes
Primary Outcome Measures
Total pathological complete response (tpCR: ypT0-is/ypN0)
Secondary Outcome Measures
Breast pathological complete response (bpCR：ypT0-is)
Residual cancer burden (RCB)
Best overall response rate (BORR)
Overall survival (OS)
Disease-free survival (DFS)
Event-free survival (EFS)
Health-related quality of life (HRQOL) (EORTC QLQ-C30)
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)
Health-related quality of life (HRQOL)
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.
Full Information
NCT ID
NCT05635487
First Posted
November 15, 2022
Last Updated
March 18, 2023
Sponsor
Shengjing Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05635487
Brief Title
A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Official Title
A Single-arm, Phase II Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
SHR-A1811, Pyrotinib, HER2-positive Breast Cancer, Neoadjuvant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-A1811+Pyrotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-A1811
Intervention Description
SHR-A1811
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
Pyrotinib
Primary Outcome Measure Information:
Title
Total pathological complete response (tpCR: ypT0-is/ypN0)
Time Frame
At the time of surgery
Secondary Outcome Measure Information:
Title
Breast pathological complete response (bpCR：ypT0-is)
Time Frame
At the time of surgery
Title
Residual cancer burden (RCB)
Time Frame
At the time of surgery
Title
Best overall response rate (BORR)
Time Frame
During 18 weeks of the neoadjuvant treatment
Title
Overall survival (OS)
Time Frame
5 years
Title
Disease-free survival (DFS)
Time Frame
5 years
Title
Event-free survival (EFS)
Time Frame
5 years
Title
Health-related quality of life (HRQOL) (EORTC QLQ-C30)
Description
The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)
Time Frame
During 18 weeks of the neoadjuvant treatment
Title
Health-related quality of life (HRQOL)
Description
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.
Time Frame
During 18 weeks of the neoadjuvant treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Niu, MD
Phone
86-18940256668
Email
niunannancy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caigang Liu, MD
Organizational Affiliation
Shengjing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shengjing Hospital affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Niu, MD
First Name & Middle Initial & Last Name & Degree
Cai-Gang Liu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
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