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

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05834699
• Lead Sponsor: Beijing 302 Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-04-28
• Last Update Posted: 2023-04-28
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Fifth Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China