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

China Medical University

Status and phase

Enrolling

Phase 2

Conditions

HER2-positive Breast Cancer

Treatments

Drug: SHR-A1811

Drug: Pyrotinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05635487

MUKDEN 07

Details and patient eligibility

About

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.

Enrollment

65 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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