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

NCT04929548 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: WuhanU
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Neoadjuvant; Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Complete remission of pathology

  6 months

Secondary Outcomes (2)

• RFS

  5 years

• OS

  5 years

Study Arms (1)

ECPy-THP Programs

EXPERIMENTAL

Epirubicin 100 mg/m2, iv cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po 4-week treatment, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + patuximab 420 mg (first dose 840 mg), iv ,po 4 weeks of treatment

Drug: Pyrotinib Maleate Tablets

Interventions

Pyrotinib Maleate Tablets DRUG

Addition of Pyrotinib in the EC phase to the standard treatment EC-THP regimen recommended by the guidelines.

ECPy-THP Programs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Expected survival of not less than 12 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hou jinxuan

CONTACT

+86 13971431260; jhou@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: January 5, 2022
• Primary Completion: January 5, 2022
• Study Completion (Estimated): September 20, 2027
• Last Updated: January 5, 2022

Record last verified: 2022-01