Drexel Hill

Researchers are investigating the combination of ribociclib and standard adjuvant endocrine therapy ET to assess its effect on invasive breast cancer-free survival iBCFS in adults with hormone receptor-positive HR, HER2-negative early breast cancer at Anatomic Stage Groups III, IIB, and a subset of IIA. This phase IIIb, open-label, single-arm study involves patients close to typical clinical practice settings to better understand the treatments efficacy and safety. Participants receive ribociclib 400 mg orally once daily on days 1 to 21 of each 28-day cycle, alongside daily ET for 36 months, approximately 39 cycles. ET options vary by menopausal status and sex, including letrozole, anastrozole, or exemestane for postmenopausal women, and the same drugs combined with goserelin or leuprolide injections for preperimenopausal women and men. The treatment period starts with the first dose of ribociclib and ends 30 days after the last dose, followed by a safety follow-up call. During the study, participants undergo screening before treatment begins. After completing treatment, they enter a follow-up period lasting until death, withdrawal, loss to follow-up, or up to 48 months after the last participant starts treatment. Researchers monitor outcomes including iBCFS at 3 years, adverse events, various survival measures, dose intensity, treatment discontinuation timing, and quality of life assessments up to approximately 6 years. Safety follow-up is conducted 30 days post-treatment to ensure participant well-being.

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.