Phase III Study of Capivasertib with Standard Endocrine Therapy in Adults with HRHER2- Advanced Breast Cancer After Endocrine Treatment Progression

What this Trial Is About

Researchers are evaluating capivasertib alongside standard endocrine treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer that has progressed after prior endocrine therapy. This phase III, multicenter trial aims to assess the time patients remain on capivasertib before needing another treatment and how adherence to treatment affects quality of life. The study uses historical data as a control group and includes optional eHealth support for participants. Participants receive capivasertib orally at 400 mg twice daily for four days followed by three days off, combined with standard endocrine treatment such as fulvestrant and GnRH agonists for pre- or peri-menopausal women. The treatment continues until disease progression, death, intolerable side effects, or the end of the study. Some participants may use eHealth tools to support adherence and quality of life tracking. During the study, participants are monitored through regular clinical assessments, laboratory tests, and standardized quality of life questionnaires. Researchers measure the time until next treatment and deterioration in quality of life, alongside progression-free and overall survival. The study follows each patient from inclusion until death or study completion, with a minimum follow-up of 36 months after recruitment ends, totaling several years of observation.

Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment