Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer

NCT06877416 | Recruiting

• 1 other identifier: 20252696
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibody-drug Conjugates; HER2-low Breast Cancer; Breast Neoplasms

Keywords

Antibody-drug conjugates; HER2-low Breast Cancer; Retrospective Studies

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

  From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary Outcomes (1)

• Overall survival

  From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.

Study Arms (8)

First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan

Other: Non-intervention research

First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan

Other: Non-intervention research

First-line RC48 → Second-line Trastuzumab Deruxtecan

Other: Non-intervention research

First-line Trastuzumab Deruxtecan → Second-line RC48

Other: Non-intervention research

First-line SKB264 → Second-line Trastuzumab Deruxtecan

Other: Non-intervention research

First-line Trastuzumab Emtansine → Second-line TQB2102

Other: Non-intervention research

First-line TQB2102 → Second-line Trastuzumab Deruxtecan

Other: Non-intervention research

First-line RC48 → Second-line TQB2102

Other: Non-intervention research

Interventions

Non-intervention research OTHER

Non-intervention research

First-line RC48 → Second-line TQB2102; First-line RC48 → Second-line Trastuzumab Deruxtecan; First-line SKB264 → Second-line Trastuzumab Deruxtecan; First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan; First-line TQB2102 → Second-line Trastuzumab Deruxtecan; First-line Trastuzumab Deruxtecan → Second-line RC48; First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan; First-line Trastuzumab Emtansine → Second-line TQB2102

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 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) who received sequential administration of two or more antibody-drug conjugates (ADCs).

You may qualify if:

• 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.

You may not qualify if:

• Concomitant with other tumor components at the time of diagnosis;
• Have a history of any other malignant tumors;
• Lack of complete data

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yang Yalan, Bachelor

CONTACT

+8613826282096; yangylan7@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: January 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)