Randomized Trial Comparing Timing of Antibody Drug Conjugate and Chemotherapy in Women With Advanced HER2-Negative Breast Cancer Ages 18 to 75

What this Trial Is About

Researchers are conducting a randomized controlled trial to determine the best timing for antibody drug conjugate ADC therapy in treating advanced HER2-negative breast cancer in women aged 18 to 75 years. The main goal is to compare progression-free survival after two lines of therapy between starting treatment with ADC followed by chemotherapy versus chemotherapy followed by ADC. Secondary goals include comparing overall survival, side effects, patient experiences, cost-effectiveness, and identifying biomarkers that may predict benefit from frontline ADC therapy. Participants will be assigned to one of two groups one group receives an ADC agent as second-line treatment until disease progression or unacceptable side effects, then chemotherapy as third-line treatment the other group receives chemotherapy first, followed by ADC as third-line therapy. The choice of ADC or chemotherapy drugs will depend on the patients cancer subtype and will be decided by the study doctors. Treatments continue until disease progression or unacceptable toxicity occurs. During the study, participants will undergo regular monitoring for disease progression and side effects, with assessments of patient-reported outcomes. Researchers will measure progression-free survival up to about 20 months and overall survival up to about 40 months. Safety and treatment effects will be evaluated throughout, and participants are expected to comply with study procedures and visits until study completion, anticipated by the end of 2026.

Optimal Application Timing of ADC Drugs for Advanced Breast Cancer