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

Phase 2

Recruiting

• Conditions: HER2-positive Breast Cancer
• Interventions: Drug: SHR-A1811; Drug: Pyrotinib

• Registration Number: NCT05635487
• Lead Sponsor: Shengjing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-02
• Study Start: 2023-03-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-A1811+Pyrotinib	SHR-A1811	-
SHR-A1811	SHR-A1811	-
SHR-A1811+Pyrotinib	Pyrotinib	-

Primary Outcome Measures

Name	Time	Method
Total pathological complete response (tpCR: ypT0-is/ypN0)	At the time of surgery

Secondary Outcome Measures

Name	Time	Method
Best overall response rate (BORR)	During 18 weeks of the neoadjuvant treatment
Health-related quality of life (HRQOL) (EORTC QLQ-C30)	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)
Event-free survival (EFS)	5 years
Health-related quality of life (HRQOL)	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.
Breast pathological complete response (bpCR：ypT0-is)	At the time of surgery
Overall survival (OS)	5 years
Disease-free survival (DFS)	5 years
Residual cancer burden (RCB)	At the time of surgery

Trial Locations

Locations (1)

Shengjing Hospital affiliated to China Medical University; 🇨🇳 Shenyang, Liaoning, China