Evaluation of Safety and Efficacy of Elacestrant in Combination Therapies for Patients with Metastatic Breast Cancer: A Phase 1b/2 Open-Label Umbrella Study

The primary objective of this study is to evaluate the **safety** and **efficacy** of Elacestrant in various combinations for patients with **metastatic breast cancer**. This is clinically relevant as metastatic breast cancer represents an advanced stage of the disease where treatment options are limited, and improving therapeutic outcomes is crucial for patient survival and quality of life.

The clinical trial involves a total of **320 participants** diagnosed with **breast cancer**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria. The selection process aimed to encompass a diverse demographic to ensure comprehensive data collection and analysis.

The clinical trial is designed to evaluate the **safety** and efficacy of Elacestrant in various combinations for patients diagnosed with **metastatic breast cancer**. This study is structured as a Phase 1b/2, open-label umbrella trial, which means that it will not employ blinding or a control group, allowing for the direct observation of treatment effects across different patient cohorts. The trial is expected to commence recruitment on October 20, 2023, and is projected to conclude by December 14, 2027, encompassing a comprehensive duration to assess long-term outcomes and safety profiles.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This initial visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful enrollment, participants will attend regular follow-up visits, which are designed to monitor treatment response, manage any adverse events, and ensure adherence to the study protocol. The frequency and specific assessments conducted during these visits will be determined by the study's detailed protocol. The trial will culminate in an end-of-study visit, where final evaluations will be conducted to gather comprehensive data on the treatment's efficacy and safety.

The expected length of participant involvement will vary depending on individual response to treatment and the specific cohort assignment within the umbrella study. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study procedures, or if the investigator deems it in the participant's best interest to withdraw. The study's design and procedures are meticulously crafted to ensure the collection of robust data while prioritizing participant safety and well-being throughout the trial duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available. Additionally, details about drug administration, dosing schedules, and participant compliance monitoring are not included in the source data. As such, no further information can be offered regarding the substances or treatments involved in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 20, 2023, with an estimated completion date of December 14, 2027. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data is consistent and reliable throughout the study duration. The trial's design and execution will adhere to the rigorous standards expected in Phase 3 clinical trials, ensuring that the results are scientifically valid and applicable to the broader patient population.