NCT06877416 Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer
| NCT ID | NCT06877416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Antibody-drug Conjugates |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2020-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06877416 clinical trial?
This trial is open to participants of all sexes, studying Antibody-drug Conjugates. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06877416 currently recruiting?
Yes, NCT06877416 is actively recruiting participants. Contact the research team at yangylan7@mail2.sysu.edu.cn for enrollment information.
Where is the NCT06877416 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06877416 clinical trial?
NCT06877416 is sponsored by Sun Yat-sen University. The trial plans to enroll 700 participants.