Evaluation of Talimogene Laherparepvec and Atezolizumab Combination in Residual Breast Cancer Post-Neoadjuvant Chemotherapy in Pre and Post-Menopausal Women

The primary objective of this study is to evaluate the efficacy of combining **Talimogene Laherparepvec**, a modified herpes virus, with **atezolizumab**, a monoclonal antibody, in patients with residual breast cancer following conventional chemotherapy during the early stage of the disease. This combination therapy is being investigated in pre and post-menopausal women with resectable primary breast cancer who exhibit residual disease after neoadjuvant chemotherapy. The clinical relevance of this study lies in its potential to improve treatment outcomes for patients with residual breast cancer, a condition that poses a significant challenge in achieving complete remission and reducing recurrence rates.

The clinical trial involves a study population consisting exclusively of **female** participants, specifically targeting **pre and post-menopausal women** diagnosed with resectable primary **breast cancer** who exhibit residual disease following neoadjuvant chemotherapy. The age range of the participants is categorized under code "3," which typically includes adults, though the specific age range is not detailed. The trial does not include male subjects, and no vulnerable populations are selected for this study. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity. Additionally, key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed to evaluate the combination of **Talimogene Laherparepvec**, a modified herpes virus, with **atezolizumab**, a monoclonal antibody, in patients with residual breast cancer following conventional chemotherapy during the early stage of the disease. This study targets pre and post-menopausal women with resectable primary breast cancer who exhibit residual disease after neoadjuvant chemotherapy. The trial is structured as a Phase 3, randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the actual treatment versus a placebo, thereby minimizing bias and enhancing the reliability of the results.

The trial commenced recruitment on January 9, 2019, and is projected to conclude by November 30, 2025. 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 randomized into treatment groups. Regular follow-up visits will be scheduled to monitor the participants' health, treatment efficacy, and any adverse effects. These visits are crucial for collecting data on primary and secondary endpoints, although specific endpoints are not detailed in the available data. The study will culminate in an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the treatment regimen.

The expected duration of participant involvement will vary depending on individual response to treatment and adherence to the study protocol. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or if the study is terminated for any reason. The trial's design and procedures are meticulously crafted to ensure the safety and well-being of participants while striving to achieve meaningful scientific insights into the treatment of residual breast cancer.

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 the administration of other medicinal products or their role in the trial.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is not included in the available data. The documentation lacks specifics on the **product's authorization status**, pharmaceutical form, and the origin of the active substances.

The clinical trial is in Phase 3 and is scheduled to conclude on November 30, 2025. The recruitment for the trial began on January 9, 2019. The trial is categorized under trial category 1, with a trial category ID of 50101. The efficacy of the intervention will be assessed through parameters that are not specified in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not detailed in the available information. The trial's primary and secondary endpoints, as well as any specific tools or instruments used for efficacy assessments, are not mentioned in the source material. The trial's main objective and the medical condition being studied are also not provided.