Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP

• Status: Not yet recruiting
• Trial end date: 2027-09-20
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan University
• Treatments: Maleic acid

Criteria

Inclusion Criteria:

• Female patients aged 18-70 years.

• ECOG score must be 0 or 1.

• Patients with clinical stage II to III new breast cancer, all diagnosed by hollow-core needle aspiration biopsy pathological histology prior to treatment and surgically resectable breast cancer with positive immunohistochemical staining (IHC) for HER2 (3+) or HER2 (2+) supplemented with fluorescence in situ hybridization technique (FISH).

• The presence of at least one measurable lesion according to RECIST 1.1 criteria.

• Exclusion of distant metastases by abdominal B-ultrasound, chest X-ray and whole-body bone scan prior to neoadjuvant chemotherapy, and for lymph nodes in the enlarged area fine needle aspiration cytology is required to clarify the presence of tumor metastases without a history of remaining malignancies.

• Expected survival of not less than 12 weeks.

• No previous treatment, including chemotherapy, radiotherapy, targeted therapy, and biologic therapy. -Exclusion Criteria

Exclusion Criteria:

• Female patients of childbearing age who are pregnant, breastfeeding, or unwilling to use effective contraception throughout the trial period.

• Patients with combined severe cardiac, hepatic, renal, or endocrine system diseases and with expected survival of < 2 years for the above diseases.

• Inability to swallow, intestinal obstruction, the presence of other factors affecting drug administration and absorption or a history of allergy to this drug

• Karnofsky scale score below 60

• Patients with metastatic breast cancer or bilateral breast cancer.

• Patients with inflammatory breast cancer.

• Those with a left ventricular ejection fraction (LVEF) <55% on echocardiography

• Those who are deemed by the personnel to be otherwise unsuitable for clinical trials.