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

NCT ID: NCT04929548

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2027-09-20

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.

Detailed Description

Recruiting patients with clinical stage II to III HER2-positive breast cancer for primary treatment, eligible subjects will be enrolled as follows： 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.Eligible subjects who met the enrollment criteria and signed the informed consent form entered the trial period and received epirubicin 100 mg/m2, iv cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po for 4 weeks, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + pertuzumab 420 mg (first dose 840 mg), iv ,po 4 cycles of treatment. Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy was continued after surgery: trastuzumab + patuximab for 1 year.

Eligible subjects (20) who met the nadir criteria and signed the informed consent form entered the trial period and received the ECPy-THP regimen: i.e., epirubicin 100 mg/m2, iv + cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po 4 cycles, 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 cycles of treatment. If the efficacy of 4 cycles was evaluated as PD or SD, the regimen was promptly adjusted for surgical treatment.

Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy was continued after surgery: patients who reached pCR continued trastuzumab + pertuzumab for 1 year, and non-pCR patients were treated according to the guideline-recommended backline regimen.

All patients underwent surgery or radiotherapy continuation within 16-20 d after completion of the neoadjuvant chemotherapy cycle, and the efficacy was assessed 1 to 2 d before continuation of treatment.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECPy-THP Programs

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

Group Type: EXPERIMENTAL

Pyrotinib Maleate Tablets

Intervention Type: DRUG

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

Interventions

Pyrotinib Maleate Tablets

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

Intervention Type: DRUG

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Gaosong Wu, Ph D, MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hou jinxuan

Role: CONTACT

jhou@whu.edu.cn

+86 13971431260

Other Identifiers

WuhanU

Identifier Type: -

Identifier Source: org_study_id