Ravensburg

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 the drug LP352 in a phase 3, randomized, double-blind, placebo-controlled trial to study its effects on seizures in children and adults with Dravet Syndrome DS. This serious condition involves various seizure types with onset between 1 and 20 months of age. The study aims to test the efficacy, safety, and tolerability of LP352 compared to placebo over a total duration of about 24 months. Participants will be randomly assigned to receive either LP352 or a matching placebo. LP352 or placebo will be given orally or through a feeding tube. The study includes three main phases a Screening phase, a Titration period where doses are gradually increased to the highest tolerated level, and a Maintenance period to assess ongoing treatment effects. Afterward, participants will undergo a Taper period to reduce dosing and a Follow-Up phase for observation. During the study, participants will be monitored for seizure frequency changes, safety, and tolerability. Researchers will track countable motor seizures and measure percent change compared to baseline over up to 15 weeks. Participants or caregivers will complete seizure diaries, and stable antiseizure medication use is required. Safety evaluations will continue up to 21 weeks, with study visits scheduled throughout these phases. Total participation lasts approximately two years.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the effects of the drug imlunestrant LY3484356 in premenopausal women with early estrogen receptor-positive ER, HER2-negative breast cancer. The study includes two groups one that explores imlunestrant alone or combined with ovarian suppression, and another that studies imlunestrant without ovarian suppression. The trial compares imlunestrants impact on breast cancer cells and ovarian function to tamoxifen, a known treatment. Participants in Cohort 1 will receive imlunestrant orally either alone or with goserelin a drug given by injection to suppress ovarian function for up to 29 days. Some in this group will take tamoxifen orally as a comparator. Cohort 2 participants will take imlunestrant or tamoxifen orally for up to 6 months without ovarian suppression. The study is open-label, randomized, and phase 2, designed to assess treatment effects in parallel groups. During the study, participants will provide tumor samples before and during treatment, and researchers will monitor changes in specific cancer markers like Ki-67, estrogen receptor ER, and progesterone receptor PR expression. They will also track the rate of ovarian cysts up to 180 days. Participants must attend scheduled visits for evaluations, including performance status checks and safety assessments. The trial is expected to continue until December 2029.

Researchers are evaluating the effect of adding capivasertib to fulvestrant compared with fulvestrant alone as neoadjuvant treatment for women with primary high-risk lobular breast cancer that is hormone receptor positive and HER2 negative. This phase II, open-label, randomized study focuses on measuring the complete cell cycle arrest CCCA by assessing Ki67 levels at baseline, week 2, and week 10. The study aims to identify patients who may benefit from combined treatment and potentially avoid chemotherapy, considering the unique characteristics of invasive lobular breast cancer. Participants are randomly assigned to one of two treatment groups. One group receives capivasertib orally twice daily for 4 days followed by a 3-day break for 2 weeks, then continues this capivasertib schedule combined with fulvestrant injections every 28 days for an additional 8 weeks, totaling four doses of fulvestrant. The other group receives fulvestrant injections alone on the same schedule for 10 weeks. Treatment continues until surgery, disease progression, unacceptable side effects, or patient withdrawal. During the study, all patients will undergo core biopsies before and after treatment to measure Ki67 levels. Researchers will assess safety, pathological response, breast conservation rates, and survival outcomes. Patients will be monitored throughout treatment and follow-up, which may last up to two years to assess invasive disease-free survival and overall survival. Additional therapies such as surgery, chemotherapy, or radiotherapy will be given as needed outside the trial according to standard care.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

Researchers are investigating the effects of stopping CDK46 inhibitors in women with metastatic hormone receptor HR positive, HER2 negative breast cancer who have maintained disease control after long-term treatment. This phase II trial aims to evaluate whether disease stability continues when CDK46 inhibitors are discontinued after at least 12 months of combined treatment with endocrine therapy. The study is open-label, randomized, and conducted at multiple centers. Participants are randomly assigned to one of two groups one group continues both CDK46 inhibitor treatment such as Palbociclib or Abemaciclib and endocrine therapy, while the other group discontinues the CDK46 inhibitor but continues endocrine therapy alone. The study monitors disease progression and treatment effects over time, with a focus on how long patients remain free from disease worsening after stopping the CDK46 inhibitor. During the study, participants will be regularly assessed for disease progression, safety, and quality of life using questionnaires and clinical evaluations. Researchers will measure progression-free survival at 12 months and up to 54 months, time to treatment failure, time to first chemotherapy use, and monitor adverse events. The total participation duration may extend beyond four years, with ongoing evaluations to understand long-term outcomes and safety after stopping the CDK46 inhibitor.

Researchers are investigating the prevalence of ESR1 mutation after endocrine therapy and evaluating quality of life, tolerability, safety, and treatment details in postmenopausal women with locally advanced or metastatic estrogen receptor-positive ER HER2-negative breast cancer that has ESR1 mutations. This observational study focuses on women receiving second-line treatment with elacestrant in routine clinical settings, aiming to understand real-world outcomes and adverse event management. Participants receive elacestrant according to its Summary of Product Characteristics SmPC, with treatment decisions guided by the investigator. The study includes two groups patients with ESR1 mutated tumors and those with ESR1 wildtype tumors. ESR1 mutation testing may occur after inclusion, and patients with proven ESR1 mutations must be enrolled within two weeks after starting elacestrant treatment. During the study, participants undergo assessments including evaluations of global health, functional and symptom scores, and quality of life measures using tools like the EORTC QLQ-C30 and EQ-5D-5L from enrollment up to 11 months. Safety monitoring includes tracking adverse events and liver function tests from treatment start until 30 days after stopping elacestrant, for up to 24 months. Additional data collected covers patient and disease characteristics, treatment details, dose modifications, and subsequent therapies, providing comprehensive real-world insights.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.