Optimal Application Timing of ADC Drugs for Advanced Breast Cancer
ConditionBreast Cancer Females
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorLiaoning Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
Qualifiers
Female patients aged 18-75 years;
Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+/ISH-, IHC 1+/ISH-, and IHC 0/ISH- subtypes;
Completed first-line combination chemotherapy for advanced/metastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);
Electrocorticography (ECOG) performance status < 2;
Disqualifiers
Prior treatment with an ADC after disease recurrence or metastasis;
Pregnant or breastfeeding women;
No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;
Symptomatic brain parenchymal and/or leptomeningeal metastases with symptoms not adequately controlled by treatment;
Trial design
Treatments tested in this trial
- Antibody drug conjugate
- Chemotherapy
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Liaoning Cancer Hospital & Institute
Lead sponsor
National Cancer Center, China
Collaborator
Source ClinicalTrials.gov