Exploring treatment strategies for HER2-low breast cancer using antibody-drug conjugates
A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer
This study looks at how different treatment plans using antibody-drug conjugates can help people with HER2-low breast cancer and what factors might affect their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | trastuzumab, sacituzumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06877416 on ClinicalTrials.gov |
What this trial studies
This observational study retrospectively analyzes clinical data from patients with HER2-low breast cancer who have been treated with sequential antibody-drug conjugates (ADCs). It focuses on evaluating patient demographics, tumor characteristics, treatment regimens, survival outcomes, and safety profiles. The study also integrates genomic data to investigate resistance mechanisms and identify potential prognostic biomarkers. By examining the efficacy of different ADC sequencing approaches, the research aims to provide insights into optimal treatment strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with HER2-low breast cancer who have received sequential treatment with two or more ADCs.
Not a fit: Patients with other malignant tumors or incomplete clinical data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with HER2-low breast cancer, enhancing their survival outcomes.
How similar studies have performed: While there is ongoing research into ADCs for breast cancer, this specific approach focusing on HER2-low patients and sequential treatment strategies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Concomitant with other tumor components at the time of diagnosis; * Have a history of any other malignant tumors; * Lack of complete data
Where this trial is running
Guangzhou, Guangdong
- Sun yat-sen University Cancer — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yang Yalan, Bachelor
- Email: yangylan7@mail2.sysu.edu.cn
- Phone: +8613826282096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.