Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer

NCT07635342 | Recruiting Phase 2

• 1 other identifier: OBU-BC-II-167
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer. Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.

Conditions

HER2-positive Breast Cancer

Keywords

Neoadjuvant Therapy; Pyrotinib; Trastuzumab; Pathological Complete Response

Outcome Measures

Primary Outcomes (1)

• Total Pathological Complete Response Rate

  Total pathological complete response is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes after neoadjuvant therapy.

  At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation

Secondary Outcomes (7)

• Secondary Outcome Measure

  At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation

• Lymph Node Pathological Complete Response Rate

  At the time of surgery after completion of neoadjuvant therapy, approximately 24 weeks after treatment initiation

• Objective Response Rate

  From baseline to completion of neoadjuvant therapy, approximately 24 weeks

• Event-Free Survival

  From enrollment to the first documented event or death, assessed up to 3 years

• Distant Disease-Free Survival

  From enrollment to distant metastasis or death, assessed up to 3 years

Study Arms (1)

Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy

EXPERIMENTAL

Participants will receive 8 cycles of neoadjuvant treatment. Pyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. Trastuzumab will be administered intravenously at a loading dose of 8 mg/kg in Cycle 1, followed by 6 mg/kg on Day 1 of each 3-week cycle. During the first 4 cycles, participants will receive pegylated liposomal doxorubicin hydrochloride 35 mg/m² and cyclophosphamide 600 mg/m² intravenously on Day 1 of each 3-week cycle. During the subsequent 4 cycles, participants will receive paclitaxel for injection albumin bound 230-260 mg/m² intravenously on Day 1 of each 3-week cycle.

Drug: Pyrotinib Maleate; Drug: Trastuzumab (H, 8mg/kg; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: Cyclophosphamide; Drug: Paclitaxel for Injection Albumin Bound

Interventions

Pyrotinib Maleate DRUG

Pyrotinib maleate will be administered orally at 400 mg once daily from Day 1 of Cycle 1. It should be taken within 30 minutes after breakfast and continued throughout the neoadjuvant treatment period.

Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy

Cyclophosphamide DRUG

Cyclophosphamide will be administered intravenously at 600 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment in combination with pegylated liposomal doxorubicin hydrochloride, pyrotinib, and trastuzumab.

Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy

Paclitaxel for Injection Albumin Bound DRUG

Paclitaxel for injection albumin bound will be administered intravenously at 230-260 mg/m² on Day 1 of each 3-week cycle for the subsequent 4 cycles of neoadjuvant treatment in combination with pyrotinib and trastuzumab.

Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy

pegylated liposomal doxorubicin hydrochloride DRUG

Pegylated liposomal doxorubicin hydrochloride will be administered intravenously at 35 mg/m² on Day 1 of each 3-week cycle for the first 4 cycles of neoadjuvant treatment.

Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy

Trastuzumab (H, 8mg/kg DRUG

Trastuzumab will be administered intravenously at a loading dose of 8 mg/kg on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent 3-week cycle during neoadjuvant treatment.

Pyrotinib Plus Trastuzumab and Neoadjuvant Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18 to 65 years.
• Patients with previously untreated invasive breast cancer confirmed by pathological examination.
• HER2-positive breast cancer, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by in situ hybridization (ISH), regardless of hormone receptor status.
• Clinical stage T2N0-3M0 or any T/N1-N3M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
• At least one measurable lesion according to RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function, meeting all of the following criteria:
• Hemoglobin ≥100 g/L.
• Absolute neutrophil count ≥1.5 × 10\^9/L.
• Platelet count ≥100 × 10\^9/L.
• Total bilirubin ≤1 × upper limit of normal (ULN).
• Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN.
• Alkaline phosphatase ≤2.5 × ULN.
• Blood urea nitrogen and serum creatinine ≤1.5 × ULN.
• Left ventricular ejection fraction ≥55% by echocardiography.

You may not qualify if:

• Prior receipt of any anti-tumor therapy, including chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy.
• Concurrent receipt of any other anti-tumor therapy.
• Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
• Stage IV breast cancer.
• Breast cancer not confirmed by pathological examination.
• History of other malignancies within 5 years, except cured carcinoma in situ of the cervix.
• Severe dysfunction of major organs, including the heart, liver, or kidney.
• Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that may affect drug administration or absorption.
• Participation in another drug clinical trial within 4 weeks before enrollment.
• Known history of allergy to any component of the study treatment.
• History of immunodeficiency, including positive HIV test, hepatitis C virus infection, active hepatitis B virus infection, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
• History of any cardiac disease, including clinically significant arrhythmia requiring medication, myocardial infarction, heart failure, or any other cardiac disease judged by the investigator to make the patient unsuitable for this study.
• Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception throughout the study.
• Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or affect completion of the study, including but not limited to uncontrolled severe hypertension, severe diabetes mellitus, or active infection.
• Clear history of neurological or psychiatric disorders, including epilepsy or dementia.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (1)

• Xuhong J, Qi X, Tang P, Fan L, Chen L, Zhang F, Tan X, Yan W, Zhong L, He C, Liang Y, Ren L, Wang M, Zhang Y, Jiang J. Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1909-e1920. doi: 10.1002/onco.13546. Epub 2020 Oct 20.

  PMID: 33000490 BACKGROUND

MeSH Terms

Interventions

Trastuzumab; Protons; Cyclophosphamide; Paclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes

Study Officials

• Zhenchuan Song

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenchuan Song, MD

CONTACT

18531117857; songzhch@hotmail.com

Lina Zhang, MD

CONTACT

+86 185 3111 7825

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Breast Center

Model Details: All enrolled participants will receive the same single-arm neoadjuvant treatment regimen consisting of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide for 4 cycles, followed by paclitaxel for injection albumin bound combined with pyrotinib and trastuzumab for 4 cycles.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: April 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)