NCT06797622

Heterogeneity of 68Ga-FAPI Uptake As Imaging Biomarker in T-DXd Treatment for Brain Metastasis of HER2 Positive Breast Cancer

An Open-label Positron Emission Tomography (PET) Study to Investigate the Heterogeneity of 68Ga-FAPI Uptake Predicting the Response of T-DXd Treatment for Brain Metastasis in Patients with HER2-positive Advanced or Metastatic Breast Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to explore the predictive value of the heterogeneity of 68Ga-FAPI PET-CT uptake before treatment on the response of T-DXd treatment in patients with brain metastases of HER2-positive breast cancer. The patient underwent 68Ga-FAPI PET-CT examinations within 2 weeks before and after 2 cycles of T-DXd treatment. Heterogeneity index, SUVmax, SUVmean and other uptake values were collected to investigate the association with efficacy of T-DXd.

Conditions

• Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan (T-DXd)	Trastuzumab deruxtecan (T-DXd)

Timeline

• Start date: 2025-02-15
• Primary completion: 2027-01-15
• Completion: 2027-04-15
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: China