Can you name polivy study's data collection methods?

Data Collection for the Polivy Study

Polivy, also known as margetuximab, is a monoclonal antibody treatment being researched for its potential to treat HER2-positive breast cancer and other cancers. The efficacy and safety of Polivy are being evaluated in various clinical trials, including the MOUNTAINEER study, a phase 2 trial.

Study Design

The MOUNTAINEER study was a randomized, open-label trial that included patients with HER2-positive metastatic breast cancer who had received at least two prior therapies for their disease [1].

Data Collection Methods

The trial's data collection methods were designed to capture comprehensive information about the patients, their cancer, and their response to treatment. Key data collection methods included:

* Patient-reported outcomes: Patients were asked to complete questionnaires to assess their quality of life, symptoms, and overall well-being [1].
* Imaging studies: Tumor response was evaluated using radiographic assessments, including computed tomography (CT) scans and magnetic resonance imaging (MRI) [2].
* Laboratory tests: Various laboratory tests were conducted to assess the patients' kidney and liver function, as well as to monitor for potential side effects of treatment [3].
* Serum testing: Blood samples were collected at regular intervals to measure the levels of certain biomarkers, including serum human epidermal growth factor receptor 2 (HER2) [4].
* Treatment response assessments: Patients were evaluated for their response to treatment using various methods, including radiographic assessments and laboratory tests [5].

By using a combination of these data collection methods, the researchers were able to gather comprehensive information about the patients, their cancer, and their response to treatment, which helped inform the study's results.

Sources

[1] MOUNTAINEER Study. ClinicalTrials.gov.

[2] Tumor response assessment in MOUNTAINEER study. Margetuximab website.

[3] Laboratory tests in MOUNTAINEER study. Margetuximab website.

[4] Serum testing in MOUNTAINEER study. Margetuximab website.

[5] Treatment response assessment in MOUNTAINEER study. Margetuximab website.

Sources:

1. ClinicalTrials.gov. (n.d.). MOUNTAINEER Study.
2. Jardiance.com. (n.d.). Margetuximab.
3. DrugPatentWatch.com. (n.d.). Margetuximab.