Back to resultsNeoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib, trastuzumab, paclitaxel-albumin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring HER2-enriched, Pyrotinib, neoadjuvant therapy, pCR
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Sites / Locations
- JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pyrotinib, trastuzumab, paclitaxel-albumin
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators
pCR
Secondary Outcome Measures
Event-free survival
EFS
Objective Response Rate
ORR
minimal residual lesions
MRD
Full Information
NCT ID
NCT05659056
First Posted
December 2, 2022
Last Updated
June 11, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05659056
Brief Title
Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer
Official Title
Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
HER2-enriched, Pyrotinib, neoadjuvant therapy, pCR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pyrotinib, trastuzumab, paclitaxel-albumin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pyrotinib, trastuzumab, paclitaxel-albumin
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators
Description
pCR
Time Frame
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 Outcome Measure Information:
Title
Event-free survival
Description
EFS
Time Frame
Following surgery until year 2
Title
Objective Response Rate
Description
ORR
Time Frame
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)
Title
minimal residual lesions
Description
MRD
Time Frame
Following surgery until year 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Zhou, Professor
Phone
025-68308162
Email
Zhouwenbin@njmu.edu.cn
Facility Information:
Facility Name
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Zhou, Professor
Phone
025-68308162
Email
zhouwenbin@njmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer
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