HER2 Expression of CTC to Predict Response in HER2-low Ad... | NCT05834699

Studies
HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC

NCT05834699

Sponsor

Beijing 302 Hospital

Status

Unknown status

Last Update Posted

Apr 28, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

HER2 expression of circulating tumor cells

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Apr 18, 2023

First Submission Date that Met QC Criteria

Apr 18, 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 18, 2023

Last Update Posted Date

Apr 28, 2023Actual

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

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

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
HER2 expression of circulating tumor cells	Biological	Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment in HER2-low ABC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival(PFS)	PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause	3 years

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	ORR was defined as the proportion of patients with a complete response or a partial response.	2years
Overall survival(OS)	OS was defined as the time from the start of treatment to death from any cause

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has pathologically documented breast cancer that:
1. Is unresectable or metastatic
2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
3. Has progressed on, and would no longer benefit from, endocrine therapy
4. Has been treated at least 1 prior line of chemotherapy in the metastatic setting
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Receives anti-HER2 ADC treatment
Life expectancy > 3 months
Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
ECOG ≤2

Exclusion Criteria:

Has breast cancer ever assessed with high-HER2 expression
Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Accepts Healthy Volunteers

Sex

Female

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 diagnosed with HER2-low breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Jinmei Zhou, Doctor	Contact	010-66947250		jinzhu2714@sina.com
Jinyi Xiao, Doctor	Contact	01066947250		xiaoduoduo1989@126.com

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