Schwerte

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating whether patients with hormone-receptor positive, HER2-negative early breast cancer HRHER2- eBC who have intermediate to high risk of recurrence may benefit from an initial 5-year treatment with elacestrant, with or without a CDK 46 inhibitor, followed by standard endocrine therapy ET for an additional 0 to 2.5 years. This is compared to the current standard of care ET lasting between 5 and 7.5 years, with or without CDK 46 inhibitors. The study is designed for patients identified by genomic tests like Oncotype DX and response to preoperative endocrine therapy, aiming to improve long-term survival by targeting resistance mechanisms such as ESR1 mutations. Participants are randomly assigned to one of two groups one receiving elacestrant orally for 5 years, possibly combined with ribociclib a CDK 46 inhibitor for 3 years if indicated, and the other receiving standard endocrine treatments for 5 to 10 years with optional CDK 46 inhibitors as decided by their doctor. The treatments are evaluated in a parallel study design. The trial builds on previous findings in metastatic breast cancer and early breast cancer studies exploring endocrine therapy responses and genomic risk assessments. Throughout the study, participants undergo regular clinical assessments, including tumor pathology reviews, laboratory tests, and electrocardiograms to monitor safety and treatment effects. Researchers measure outcomes such as 5-year invasive disease-free survival and other survival metrics. Participants must comply with contraception requirements and be followed for treatment adherence and safety until study completion, which is planned for up to 2033.

Triple negative breast cancer TNBC is a type of breast cancer that lacks certain receptors and tends to have a poor prognosis and aggressive behavior. The study focuses on patients with low-risk, early-stage TNBC stage I-II node-negative who generally have better outcomes, but still face significant clinical challenges. Researchers are evaluating neoadjuvant therapies to improve treatment strategies for this group, especially comparing sacituzumab govitecan alone versus its combination with pembrolizumab. Participants will receive neoadjuvant treatment for 12 weeks, either sacituzumab govitecan alone or combined with pembrolizumab. Sacituzumab govitecan is given intravenously at 10 mgkg on Days 1 and 8 every 21 days, while pembrolizumab is administered intravenously at 200 mg every three weeks. Depending on their response after 12 weeks, some patients may continue treatment for an additional 6 weeks before surgery. Patients who achieve a complete response may not require further systemic treatment, while those with residual disease may receive additional chemotherapy as decided by their investigator. Throughout the study, participants will be closely monitored with various assessments including pathological evaluation at surgery and invasive disease-free survival measured after three years. Other outcomes include overall survival and quality of life assessments. Safety and response will be regularly evaluated to guide treatment decisions. The trial aims to enroll adult women with early-stage TNBC and will continue through September 2029, with detailed follow-up planned to capture long-term outcomes.

Researchers are evaluating the best neoadjuvant therapy for patients with less advanced HER2-positive early breast cancer EBC. This Phase 2 trial focuses on improving treatment outcomes by comparing trastuzumab-deruxtecan T-DXd with standard chemotherapy combined with trastuzumab and pertuzumab. The study targets patients with low to intermediate risk HER2 EBC, aiming to show higher rates of complete tumor response and excellent survival outcomes. Participants receive different treatment regimens depending on their risk group and assigned study arm. Treatments include 12 or 18 weeks of T-DXd alone or combined with standard chemotherapy, trastuzumab, and pertuzumab. After neoadjuvant treatment, post-neoadjuvant therapy with T-DXd or standard care continues for up to one year, with adjustments based on tumor response. Some patients may receive additional chemotherapy depending on residual tumor burden. During the study, participants undergo regular evaluations including tumor response assessments and safety monitoring for adverse drug reactions. Key outcomes measured are pathological complete response rate after neoadjuvant therapy and distant disease-free survival after three years. Researchers also track various survival outcomes, quality of life, and treatment-related side effects over time. Participants are followed until study completion in 2030, with detailed monitoring throughout the treatment and follow-up phases.

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.

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.