Investigating biomarkers and clinical features in metastatic breast cancer patients treated with CDK4/6 inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines the clinical progression and treatment responses of patients with metastatic breast cancer who are treated with CDK4/6 inhibitors. It aims to collect and analyze various biological samples, including blood and tissue, to understand cancer behavior and drug resistance. The study will also explore pharmacogenomic relationships to optimize drug dosing and develop patient-derived models to assess resistance mechanisms. Data will be gathered from electronic medical records and through direct sample collection to inform clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Agnieszka K Witkiewicz — Roswell Park Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.