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

NCT05635487 | Recruiting Phase 2

• 1 other identifier: MUKDEN 07
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Keywords

SHR-A1811; Pyrotinib; HER2-positive Breast Cancer; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (tpCR: ypT0-is/ypN0)

  At the time of surgery

Secondary Outcomes (8)

• Breast pathological complete response (bpCR：ypT0-is)

  At the time of surgery

• Residual cancer burden (RCB)

  At the time of surgery

• Best overall response rate (BORR)

  During 18 weeks of the neoadjuvant treatment

• Overall survival (OS)

  5 years

• Disease-free survival (DFS)

  5 years

Study Arms (2)

SHR-A1811+Pyrotinib

EXPERIMENTAL

Drug: SHR-A1811; Drug: Pyrotinib

SHR-A1811

EXPERIMENTAL

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

SHR-A1811

SHR-A1811; SHR-A1811+Pyrotinib

Pyrotinib DRUG

Pyrotinib

SHR-A1811+Pyrotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Officials

• Caigang Liu, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Niu, MD

CONTACT

86-18940256668; niunannancy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cancer Center

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 2, 2022
• Study Start: March 16, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): February 28, 2030
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)