A Phase 2 interventional study of Antibody drug conjugate and Chemotherapy in Breast Cancer Females, sponsored by Liaoning Cancer Hospital & Institute. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Liaoning Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Liaoning Cancer Hospital & Institute is the lead sponsor of 22 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow function, defined as:
Adequate hepatic and renal function, defined as:
Exclusion Criteria:
Patients will receive an ADC agent as second-line treatment until disease progression or unacceptable toxicity, followed by physician's choice of chemotherapy as third-line treatment
Drug: Antibody drug conjugate · Drug: Chemotherapy
Patients will receive physician's choice of chemotherapy as second-line treatment until disease progression or unacceptable toxicity, followed by an ADC agent as third-line treatment.
Drug: Antibody drug conjugate · Drug: Chemotherapy
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.
Progression-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
Cost-effectiveness
Defined as the total treatment-related costs incurred after patient enrollment.
Time frame: Up to approximately 20 months
Exploratory Endpoint
The correlation between baseline tumor mutation burden level and progression-free survival 2 (PFS2).
Time frame: Up to approximately 20 months
Plan to share: No
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Liaoning Cancer Hospital & Institute