Evaluation of Preoperative Durvalumab (MEDI4736) in Patients with Early-Stage Untreated Small Triple Negative Breast Cancer

The primary objective of this study is to evaluate the short-term pre-operative administration of **Durvalumab (MEDI 4736)** in patients with early-stage, untreated small **triple negative breast cancer**. This investigation is clinically relevant as it aims to assess the potential benefits of Durvalumab in enhancing the treatment outcomes for this aggressive subtype of breast cancer, which is characterized by the absence of estrogen, progesterone, and HER2 receptors, making it challenging to treat with conventional hormone therapies.

The clinical trial focuses on participants diagnosed with **untreated small triple negative breast cancer**. The study population comprises exclusively female subjects, as male subjects are not included. The age range of participants spans from young adults to middle-aged individuals, specifically those categorized within age groups 3 and 4. The trial population is characterized by the inclusion of a vulnerable population, although specific details regarding the selection process or lifestyle considerations such as diet, physical activity, or habits are not provided. The sponsor has not disclosed the total number of participants involved in the study.

The clinical trial is designed to evaluate the efficacy of **Durvalumab** in patients with untreated small triple negative breast cancer. This study is a Phase 4 trial, which will be conducted in a randomized, double-blind, and controlled manner to ensure the reliability and validity of the results. The trial is expected to commence recruitment on December 6, 2021, and is projected to conclude by July 31, 2026, providing a comprehensive assessment over a significant period.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to determine eligibility based on predefined criteria. Following successful inclusion, participants will be randomized to receive either the investigational product or a control. Throughout the trial, follow-up visits will be scheduled at regular intervals to monitor the participants' health status, assess the treatment's efficacy, and record any adverse events. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the treatment outcomes.

The expected duration of participant involvement will vary depending on individual response and adherence to the study protocol. However, participants are generally expected to remain in the study until its conclusion unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, withdrawal of consent, or any other medical or ethical reasons deemed appropriate by the study investigators. The trial's design and procedures are structured to ensure participant safety while rigorously evaluating the investigational treatment's potential benefits.

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 these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is categorized as a Phase 4 study, with an estimated recruitment start date of December 6, 2021, and an estimated end date of July 31, 2026. Efficacy assessments will be conducted to evaluate the outcomes of the intervention. However, specific parameters or endpoints used to evaluate efficacy, such as symptom improvement scores, biomarker levels, or disease remission rates, are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters, including any validated scales, laboratory tests, or patient-reported outcomes, are also not specified. The trial's main objective and the medical condition under investigation are not disclosed in the available information. Consequently, the description of efficacy assessment is limited to the trial's phase and timeline without further specifics on the endpoints or assessment tools involved.