Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

NCT06035679 | Recruiting

• 1 other identifier: OBU-BC-II-95
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• tpCR

  total Pathological Complete Response

  at surgery

Study Arms (1)

Pyrotinib Combined With Trastuzumab and Chemotherapy

EXPERIMENTAL

T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)

Drug: Pyrotinib and Trastuzumab

Interventions

Pyrotinib and Trastuzumab DRUG

Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer

Also known as: dual HER2 blockade in the neoadjuvant setting

Pyrotinib Combined With Trastuzumab and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-75 years;
• Her2-positive breast cancer confirmed by pathology;
• invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);
• ECOG PS: 0-1 score;
• Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND)
• Normal function of major organs means that the following criteria are met:
• (1) Blood test neutrophil (ANC) \>=1.5x10\^9/L; Platelet count (PLT) \>=90x10\^9/L; Hemoglobin (Hb) \>=90g/L; (2) Total bilirubin (TBIL) \<=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=1.5xULN; Alkaline phosphatase \<=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) \<=1.5xULN; (3) Left ventricular ejection fraction (LVEF) \>=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.

You may not qualify if:

• Known allergic history of the drug components of this protocol;
• Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
• Participated in clinical trials of other antitumor drugs within four weeks;
• Stage IV (metastatic) breast cancer;
• Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
• A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension);
• Patients with active infection and severe mental illness;
• Pregnant or lactating patients;
• Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.

Sponsors & Collaborators

• Youzhi Zhu: lead

Study Sites (1)

The First Affiliated Hospital of Fujan Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Interventions

pyrotinib; Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• zhu youzhi

  First Affiliated Hospital of Fujian Medical University

  STUDY CHAIR

Central Study Contacts

zhu youzhi

CONTACT

17759120588; zhu@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 13, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)