Evaluation of Safety and Efficacy of Debio 0123 and Sacituzumab Govitecan in Advanced/Metastatic Triple-Negative or HR+/HER2- Breast Cancer

The primary objective of this study is to evaluate the **safety** and **efficacy** of the combination of Debio 0123 and sacituzumab govitecan in patients with **triple-negative** or **hormonal receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced/metastatic breast cancer**. This is clinically relevant as these subtypes of breast cancer often have limited treatment options and poor prognosis, necessitating the development of new therapeutic strategies to improve patient outcomes.

The clinical trial involves participants diagnosed with **triple-negative or HR+/HER2– advanced/metastatic breast cancer**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is designed to evaluate the **safety** and **efficacy** of a combination therapy in patients with **triple-negative** or **hormonal receptor positive/human epidermal growth factor receptor 2 negative advanced/metastatic breast cancer**. This study is structured as a **randomized, double-blind, controlled trial**. The estimated recruitment start date is January 10, 2025, with an anticipated end date of December 20, 2027, indicating a total trial duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomly assigned to receive either the investigational treatment or a control. Regular follow-up visits will be scheduled to monitor the participants' health, assess treatment response, and record any adverse events. These visits are crucial for ensuring participant safety and collecting data on the treatment's effectiveness. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted.

The expected length of participant involvement in the trial is contingent upon the individual's response to treatment and overall health status. Participants may be withdrawn from the study early if they experience significant adverse effects, if the disease progresses beyond a certain point, or if they choose to withdraw consent. The trial's design ensures that all procedures adhere to ethical standards and regulatory requirements, prioritizing participant safety and the integrity of the collected data.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatment protocols accurately.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information such as the parameters or endpoints used to evaluate efficacy, the methods and schedule for measuring, collecting, and analyzing these efficacy parameters, and any tools or instruments involved in efficacy assessments are not included. The trial is estimated to have a recruitment start date of January 10, 2025, and an estimated end date of December 20, 2027. The trial is categorized under phase 9, but further specifics on efficacy assessment are not available.