Amsterdam

Researchers are evaluating ovarian suppression in premenopausal women with hormone receptor-positive HR, HER2-negative advanced breast cancer. The study aims to assess how well ZOLADEX 10.8 mg suppresses ovarian function by measuring luteinizing hormone LH levels during treatment. This Phase 1, single-arm, open-label trial seeks to understand the degree and consistency of ovarian suppression in this patient group. Participants will receive two doses of ZOLADEX 10.8 mg as subcutaneous injections one on Day 1 Week 1 and another on Day 85 Week 12. The study focuses on tracking ovarian suppression by measuring hormone levels over the treatment period, with no placebo or comparison group involved. During the study, participants will have their LH levels measured at various time points, including Week 6 as the primary outcome and Weeks 12, 18, and 24 for secondary outcomes. Other assessments include estradiol suppression and absence of menses at these same intervals. Participants will be monitored for safety and treatment effects throughout the study which may last up to 24 weeks after treatment initiation.

Researchers are evaluating whether the combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer that remains after surgery and pre-surgical therapy. This phase 3 trial focuses on participants who have residual invasive disease following neoadjuvant therapy and surgery. The study aims to better understand outcomes for this condition where cancer persists despite earlier treatments. Participants are randomly assigned to one of two groups. One group receives SG intravenously at 10 mgkg on Days 1 and 8 of 21-day cycles along with pembrolizumab 200 mg intravenously on Day 1, repeated for up to 8 cycles. The other group receives physicians choice treatment pembrolizumab alone or pembrolizumab combined with oral capecitabine, also given over 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, or other specified reasons. During the study, participants are monitored for invasive disease-free survival up to 60 months, along with overall survival, distant disease-free survival, recurrence-free survival, and quality of life measures. Safety is assessed through tracking treatment-related adverse events and laboratory tests for up to 38 months plus 30 days. This long-term follow-up helps evaluate the impact of the treatments on disease outcomes and participant well-being.