This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer. Primary Objective: To compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer. Secondary Objectives: To compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The selection of ADC agents will be based on the patient's molecular subtype. For Hormone receptor (HR)+/HER2-low patients, anti-HER2 ADCs such as trastuzumab deruxtecan may be used. For HR+/HER2-zero patients, TROP-2-targeted ADCs such as sacituzumab govitecan are preferred. For HR-/HER2-low patients, either anti-HER2 ADCs or Trophoblast cell surface antigen 2 (TROP-2) ADCs may be considered. For HR-/HER2-zero patients, TROP-2 ADCs will be used. The specific ADC regimen will be determined at the discretion of the investigators.
The chemotherapy regimen will consist of standard second-line agents such as capecitabine, eribulin, vinorelbine, or gemcitabine. The specific chemotherapy regimen will be determined at the discretion of the investigators.
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
RECRUITINGProgression-free survival 2 (PFS2)
Progression-free survival 2 (PFS2) is defined as the time from randomization to disease progression or death (whichever occurs first) following the second treatment.
Time frame: Up to approximately 20 months
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Time frame: Up to approximately 40 months
Patient-Reported Outcomes (PROs)
Defined as reports directly from patients regarding their health status, functional status, and treatment experience during the period from randomization to disease progression, without interpretation by clinicians or others.
Time frame: Up to approximately 20 months
Time to Progression (TTP)
Defined as the time from randomization to disease progression.
Time frame: Up to approximately 20 months
Adverse event
Defined as the occurrence of adverse events after enrollment, evaluated according to NCI CTCAE version 5.0.
Time frame: Up to approximately 20 months
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