Bergisch Gladbach

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

Researchers are investigating the use of elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have a relapse detected by circulating tumor DNA (ctDNA). This international, multi-center, randomized, open-label phase III trial aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

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 evaluating the treatment and disease progression in men with recurrent or metastatic prostate cancer through a long-term registry study. The study includes patients with four distinct prostate cancer conditions: biochemical recurrence after surgery or radiation, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is studied independently during different time periods to better understand their treatment courses and disease outcomes. There is no specific treatment assigned by the study. Instead, patients receive care according to the usual medical practice at their treatment centers. Treatments may vary and are decided by each patient's doctor. Data is collected at routine visits after enrollment, then every 3 or 6 months, and whenever therapy changes. This includes recording treatments, disease status, quality of life questionnaires (FACT-P and EQ-5D-5L), and collection of biomaterial. Participants will be involved in regular follow-up visits where their disease progression and therapy details are documented. The study monitors therapy frequencies and patterns for an average of 7 years. Researchers assess these long-term outcomes along with quality of life and other clinical data to better understand prostate cancer management in real-world settings.

Researchers are evaluating the real-world clinical use and outcomes of men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with a combination of olaparib and abiraterone. The study focuses on patients who have either not previously received next-generation hormonal agents (NHA-naive) or who have been exposed to NHAs before starting this combined treatment. This prospective observational study aims to describe patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone therapy. The study will enroll patients who have started treatment with olaparib plus abiraterone after the study site became active. It will follow patients for up to 2 years to collect data on their treatment experience. No experimental interventions are administered as part of the study; instead, it observes patients receiving standard treatment in routine clinical settings. Participants will be monitored from the start of olaparib treatment until one year after the last patient enrolls. Researchers will collect clinical data to assess treatment discontinuation times and overall outcomes during this period. The study will capture information on patients’ clinical progress and any subsequent therapies, providing insights into the real-world effectiveness and use of this treatment combination.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.