Gateshead

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the effectiveness and safety of combining ribociclib with standard adjuvant endocrine therapy (ET) in patients with hormone receptor-positive (HR+), HER2-negative early breast cancer. This study focuses on patients with Anatomic Stage Group III, IIB, and certain cases of Stage IIA breast cancer. It is a phase IIIb, open-label, multicenter, single-arm trial aiming to measure invasive breast cancer-free survival over three years. Participants who complete screening will receive ribociclib at 400 mg orally once daily for 21 days followed by 7 days off, in 28-day cycles, alongside daily endocrine therapy for 36 months, roughly 39 cycles. Endocrine therapies may include letrozole, anastrozole, exemestane, or hormone-suppressing drugs like goserelin or leuprolide, administered as per standard dosing schedules. After treatment, there is a 30-day safety follow-up and a longer follow-up period lasting until death, withdrawal, loss to follow-up, or up to 48 months after the last participant's first dose. During the study, participants will be monitored for safety and treatment efficacy through regular assessments including heart monitoring via ECG, performance status checks, and laboratory tests to ensure organ function. The main outcome is the rate of invasive breast cancer-free survival at three years. Safety follow-up calls occur 30 days after the last treatment dose, and participants are followed long-term to observe any disease recurrence or other health outcomes.

Researchers are investigating whether magnetic resonance imaging (MRI) results can help select women with early breast cancer who might safely skip radiotherapy after surgery without increasing the chance of cancer returning in the same breast. The study focuses on female patients aged 50 and older with hormone receptor-positive and/or HER2-positive invasive breast cancer. It builds upon earlier findings that combining MRI and pathology can identify patients at low risk of recurrence who may not need radiotherapy, aiming to confirm these results in a larger international setting. The study compares two groups: one where radiotherapy is omitted based on pre-surgical MRI and pathology findings (Arm A), and a standard treatment group receiving usual care including radiotherapy when indicated (Arm B). Patients are selected and assigned to arms based on MRI features such as background parenchymal enhancement and tumour characteristics including size, margin clearance, nodal status, and absence of certain high-risk pathological factors. Treatment decisions and follow-up are guided by these criteria and the surgery performed. Participants will undergo assessments including pre-operative breast imaging, surgery, and pathology review. They will be monitored for cancer recurrence in the breast over a median follow-up of 5 years. Researchers will evaluate the rate of cancer returning on the same side (Ipsilateral Invasive Recurrence Rate) and also study patient-reported outcomes and health economics. The trial includes long-term follow-up to assess safety and effectiveness of omitting radiotherapy in selected patients.

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy (SG) combined with pembrolizumab compared to the treatment chosen by a doctor, which may be pembrolizumab alone or pembrolizumab with capecitabine. This study focuses on patients with triple negative breast cancer who still have invasive cancer remaining after surgery and pre-surgical treatment. The study is a phase 3, randomized, open-label trial designed to assess outcomes in this patient group. Participants receive sacituzumab govitecan-hziy and pembrolizumab through intravenous infusion as the experimental treatment. The comparison group receives the physician's choice of treatment, which involves either pembrolizumab alone intravenously or pembrolizumab combined with oral capecitabine tablets. Both treatment options follow surgery and prior therapy, targeting residual invasive disease. Throughout the study, participants are monitored up to 60 months to measure invasive disease-free survival, which indicates the time without cancer recurrence or progression. Researchers will track treatment safety and effectiveness through regular assessments. The study involves tissue sample submissions from before and after neoadjuvant therapy and surgery, performance status evaluations, organ function tests, and recovery status from surgery and radiotherapy.