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

Sponsor

Beijing 302 Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05834686

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-positive advanced breast cancer patients treated with ADC

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Biological: HER2 expression of circulating tumor cells

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-positive Advanced Breast Cancer Patients Treated With ADC

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate (ORR) [2years]
ORR was defined as the proportion of patients with a complete response or a partial response
Overall survival(OS) [5 years]
OS was defined as the time from the start of treatment to death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Has pathologically documented breast cancer that:

Is unresectable or metastatic
has confirmed HER2-positive expression defined as IHC 2+/ISH+ or IHC 3+
was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane

Has 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 uncontrolled or significant cardiovascular disease
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China	100071

Sponsors and Collaborators

Beijing 302 Hospital

Investigators

Study Director: Tao Wang, Beijing 302 Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing 302 Hospital

ClinicalTrials.gov Identifier:

NCT05834686

Other Study ID Numbers:

Breast-CTC-HER2

First Posted:

Apr 28, 2023

Last Update Posted:

Apr 28, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 28, 2023