89Zr-Trastuzumab PET Imaging in HER2-Positive Breast Cancer, Gastroesophageal Adenocarcinomas, and ERBBR2 Gene-Altered Cancers

The primary objective of the study is to evaluate the efficacy of **89Zr-Trastuzumab PET imaging** in targeting HER2-positive tumors in patients diagnosed with breast cancer, gastroesophageal adenocarcinomas, or cancers with alterations in the **ERBBR2 gene**. This imaging technique is clinically relevant as it may enhance the precision of tumor localization and characterization, potentially leading to improved treatment planning and outcomes for patients with these specific cancer types.

The clinical trial involves participants diagnosed with **breast cancer**, gastroesophageal adenocarcinomas, or cancers with alterations in the ERBBR2 gene. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. 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 in the available data.

The clinical trial is designed to evaluate the efficacy of **89Zr-Trastuzumab PET Imaging** in patients diagnosed with **breast cancer**, **gastroesophageal adenocarcinomas**, or cancers with alterations in the **ERBBR2 gene**. This study is a Phase 1 trial, characterized by a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is scheduled to commence recruitment on November 1, 2024, and is expected to conclude by November 1, 2028, encompassing a total duration of four years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits, which are structured to monitor the safety and efficacy of the intervention, as well as to collect necessary data for the study endpoints. The sequence of these visits is meticulously planned to ensure comprehensive data collection and participant safety. The trial will culminate in an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the intervention.

The expected length of participant involvement in the trial is contingent upon the individual treatment plan and the overall study timeline. However, certain conditions may necessitate early termination from the study, such as adverse reactions to the intervention, non-compliance with study protocols, or withdrawal of consent by the participant. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants throughout the study duration.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. Consequently, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be elaborated upon in the context of this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on November 1, 2024, with an estimated completion date of November 1, 2028. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize various parameters such as biomarker levels or symptom improvement scores to gather initial efficacy data. The methods for measuring and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, or patient-reported outcomes. The trial will adhere to a predefined schedule for data collection and analysis, ensuring systematic evaluation of the investigational product's effects. The absence of detailed endpoints and measurement tools in the provided data suggests that these elements will be defined in the trial's comprehensive protocol document, which will guide the execution of efficacy assessments throughout the study duration.