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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834699
• Other study ID #: Breast-CTC-HER1
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Beijing 302 Hospital
• Contact: Jinmei Zhou, Doctor
• Phone: 010-66947250
• Email: jinzhu2714[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• HER2 expression of circulating tumor cells
Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment in HER2-low ABC

Locations

Country	Name	City	State
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate (ORR)	ORR was defined as the proportion of patients with a complete response or a partial response.	2years
Secondary	Overall survival(OS)	OS was defined as the time from the start of treatment to death from any cause	5 years