A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms. This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)

• Received sequential administration of two or more ADCs

• Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

Locations
Other Locations
China
Sun yat-sen University Cancer
RECRUITING
Guangzhou
Contact Information
Primary
Yang Yalan, Bachelor
yangylan7@mail2.sysu.edu.cn
+8613826282096
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 700
Treatments
First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan
First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan
First-line RC48 → Second-line Trastuzumab Deruxtecan
First-line Trastuzumab Deruxtecan → Second-line RC48
First-line SKB264 → Second-line Trastuzumab Deruxtecan
First-line Trastuzumab Emtansine → Second-line TQB2102
First-line TQB2102 → Second-line Trastuzumab Deruxtecan
First-line RC48 → Second-line TQB2102
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov