Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors

Launched by ROSWELL PARK CANCER INSTITUTE · Aug 20, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring how patients with metastatic breast cancer respond to a type of treatment called CDK4/6 inhibitors. These medications help slow down the growth of cancer cells by blocking certain enzymes that cancer cells need to grow. The study aims to collect and analyze samples from patients, such as blood and tissue, to understand how the cancer behaves over time and why some patients may stop responding to treatments. By doing this, doctors hope to better predict treatment outcomes and improve care for patients with this type of cancer.

To participate in this trial, you need to be an adult with a specific type of breast cancer known as ER+/HER2- metastatic breast cancer, or a related high-risk early stage. You should be either currently receiving or have previously received treatment with ciclib-based therapies. The study is open to all genders, and those interested will need to sign a consent form to confirm their understanding of the study. Participants will be monitored closely and will have their medical history reviewed at a breast oncology clinic. It’s important to note that pregnant or nursing women cannot participate, and all participants must be willing to follow the study's guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All adult patients with ER+/HER2- metastatic breast cancer or HR+/HER2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study
• • This includes patients receiving standard of care therapy for ER+/HER2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at Roswell Park or St. Vincent's Hospital
• • Screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy
• • Participant must understand the prospective nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form
• Exclusion Criteria:
• • Pregnant of nursing female subjects
• • Unwilling or unable to follow protocol requirements