Pyrotinib in Women With High-risk in Early Stage Breast C... | NCT05834764

Studies
Pyrotinib in Women With High-risk in Early Stage Breast Cancer

NCT05834764

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Recruiting

Last Update Posted

Apr 28, 2023Actual

Enrollment

188Estimated

Phase

Phase 2

Conditions

HER2-positive Breast Cancer

Interventions

Pyrotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2023Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 17, 2023

First Submission Date that Met QC Criteria

Apr 26, 2023

First Posted Date

Apr 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 28, 2023Actual

Name	Class
Jiangsu HengRui Medicine Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached.

However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pyrotinib	Experimental	pyrotinib 400mg orally daily for one year	Drug: Pyrotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pyrotinib	Drug	Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）	Pyrotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Invasive Disease-free Survival (iDFS) at year 2	Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause.	From enrollment until time of events up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Disease-free Survival at year 2 (2y-DFS)	Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.	From enrollment until time of events up to 2 years
Overall Survival (OS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects voluntarily participate in this study and sign the informed consent form；
Female or male patients, aged ≥ 18 years, and ≤75 years;
ECOG PS score: 0-1;
Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
Could have been treated neoadjuvantly but have not reached pathologic complete response.

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
History of gastrointestinal disease with diarrhea as the major symptom.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoan Liu, Professor	Contact	025-68308162		liuxiaoan@126.com

Overall Officials

Name	Affiliation	Role
Xiaoan Liu, Professor	Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University	Recruiting	Nanjing	Jiangsu		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided