Incidence and Prognostic Significance of HER-2 Status Dis... | NCT05510037

Studies
Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions

NCT05510037

Sponsor

Fudan University

Status

Completed

Last Update Posted

Aug 22, 2022Actual

Enrollment

1,299Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

no intervention

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Jun 1, 2022Actual

First Submitted Date

Aug 15, 2022

First Submission Date that Met QC Criteria

Aug 19, 2022

First Posted Date

Aug 22, 2022Actual

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

Aug 19, 2022

Last Update Posted Date

Aug 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jian Zhang,MD, Director of the phase I clinical trial department, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,299Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HER2-0			Other: no intervention
HER2-LOW			Other: no intervention
HER2-POSITIVE			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention was needed	HER2-0 HER2-LOW HER2-POSITIVE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	The overall survival (OS) was defined as time from the date of initial diagnosis of recurrent/metastatic disease to the date of death from any cause	up to 200 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with available HER2 status of primary breast cancer and relapse/metastases

Exclusion Criteria:

Patients with other malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with available HER2 status of primary breast cancer and relapse/metastases

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jian Zhang, PHD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center		Shanghai			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

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided