Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

NCT05659056 | Recruiting Phase 2

• 1 other identifier: NJMU-BC01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

Conditions

Breast Cancer

Keywords

HER2-enriched, Pyrotinib, neoadjuvant therapy, pCR

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators

  pCR

  Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days)

Secondary Outcomes (3)

• Event-free survival

  Following surgery until year 2

• Objective Response Rate

  Baseline up to cycle 6 (assessed at Baseline, at the time of pre-surgery), up to approximately 5 months after neoadjuvant (each cycle is 21 days)

• minimal residual lesions

  Following surgery until year 2

Study Arms (1)

Pyrotinib, trastuzumab, paclitaxel-albumin

EXPERIMENTAL

Drug: Pyrotinib, trastuzumab, paclitaxel-albumin

Interventions

Pyrotinib, trastuzumab, paclitaxel-albumin DRUG

pyrotinib: 400mg orally daily; trastuzumab: 8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; paclitaxel-albumin: 260mg/m2, every 3 week, a total of 6 cycles

Pyrotinib, trastuzumab, paclitaxel-albumin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients, 18 years ≤ age ≤ 75 years；
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive breast cancer（early stage or locally advanced）
• HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
• Primary breast cancer;
• Known hormone receptor status.
• The organs are functioning normally, like the liver function, the renal function， and the baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
• Signed informed consent form (ICF)

You may not qualify if:

• metastatic disease (Stage IV) or inflammatory breast cancer
• Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
• Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
• A history of allergy to the drugs in this study；
• Unable or unwilling to swallow tablets

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

pyrotinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Wenbin Zhou, Professor

CONTACT

025-68308162; Zhouwenbin@njmu.edu.cn

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: Professor

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 21, 2022
• Study Start: November 29, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)