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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635487
• Other study ID #: MUKDEN 07
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2023
• Est. completion date: February 28, 2029

Study information

• Verified date: March 2023
• Source: Shengjing Hospital
• Contact: Nan Niu, MD
• Phone: 86-18940256668
• Email: niunannancy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: February 28, 2029
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• SHR-A1811
SHR-A1811
• Pyrotinib
Pyrotinib

Locations

Country	Name	City	State
China	Shengjing Hospital affiliated to China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Shengjing Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pathological complete response (tpCR: ypT0-is/ypN0)		At the time of surgery
Secondary	Breast pathological complete response (bpCR:ypT0-is)		At the time of surgery
Secondary	Residual cancer burden (RCB)		At the time of surgery
Secondary	Best overall response rate (BORR)		During 18 weeks of the neoadjuvant treatment
Secondary	Overall survival (OS)		5 years
Secondary	Disease-free survival (DFS)		5 years
Secondary	Event-free survival (EFS)		5 years
Secondary	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)	During 18 weeks of the neoadjuvant treatment
Secondary	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.	During 18 weeks of the neoadjuvant treatment