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

Exploratory Study of Triple-targeted Neoadjuvant Treatment of HER2-positive Breast Cancer With Pyrotinib in Combination With Trastuzumab and Pertuzumab

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib Maleate Tablets

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hou jinxuan; Phone Number: +86 13971431260; Email: jhou@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Pyrotinib Maleate Tablets; Addition of Pyrotinib in the EC phase to the standard treatment EC-THP regimen recommended by the guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	Complete remission of pathology	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	5 years
RFS	RELAPSE-FREE SURVIVAL	5 years

Collaborators and Investigators

• Sponsor: Wuhan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 5, 2022
• Primary Completion (ANTICIPATED): January 5, 2022
• Study Completion (ANTICIPATED): September 20, 2027

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (ACTUAL): June 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Neoadjuvant; Targeted Therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: WuhanU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No