NCT03829306

Unraveling KAdcyla Resistance In Human Epidermal Growth Factor Receptor 2(HER2) Positive Advanced Breast Cancer (KATIA)

"Unraveling KAdcyla (Trastuzumab Emtansine; T-DM1) Resistance In HER2-positive Advanced Breast Cancer (ABC): a Prospective GEICAM Study"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The study aim is to perform a comprehensive and integrated characterization of mechanisms of primary and acquired resistance to Kadcyla in a prospective cohort of progressive/recurrent HER2-positive breast cancer patients.

Detailed description

This exploratory project is a prospective and multicenter study designed to evaluate the mechanisms of primary and acquired resistance to Kadcyla in a cohort of 50 progressive/recurrent HER2+ BC patients planned to be treated with Kadcyla within the approved indication in Spain. This study will collect high quality molecular data derived from the analysis of serial biological samples (primary tumor and/or metastatic tissue, plasma, serum and whole blood samples), together with annotated clinical follow up, to reach a better understanding of the biological events that drive breast cancer progression and response/resistance to Kadcyla in ABC patients.

Conditions

• Advanced Breast Cancer

Timeline

• Start date: 2018-06-12
• Primary completion: 2022-06-21
• Completion: 2022-06-21
• First posted: 2019-02-04
• Last updated: 2023-01-13

Locations

10 sites across 1 country: Spain