Recruiting

CDK4/6 Inhibitors

Sponsor:

Roswell Park Cancer Institute

Code:

NCT04526587

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Metastatic Breast Carcinoma

Prognostic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cytology Specimen Collection Procedure

Diagnostic Laboratory Biomarker Analysis

Medical Chart Review

Study Details

Brief summary:

This study investigates the clinical course of CDK4/6 inhibitor treated patients in the real-world setting among patients with breast cancer. CDK4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Metastatic Breast Carcinoma

Prognostic Stage IV Breast Cancer AJCC v8

Study ID

NCT04526587

Start date

Jul 3, 2020

Status verified date

Nov, 2025

Completion date

Jul 3, 2035

Anticipated

Primary completion date

Jul 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

Basic science (medical chart review, biospecimen collection)

Patients electronic medical records are reviewed to capture clinical information, and patients undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples for diagnosis/treatment decision, biomarker assessments, and description of mechanisms of resistance/response related to ciclib-therapy.

Interventions

Cytology Specimen Collection Procedure

Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples

Diagnostic Laboratory Biomarker Analysis

Correlative studies

Medical Chart Review

Patient's electronic health records are reviewed

Primary outcome measure

  • Collection of clinical characteristics [ Time Frame: Up to 5 years ]
  • Overall survival on ciclib [ Time Frame: Up to 15 years ]
  • Progression-free survival on ciclib [ Time Frame: Up to 15 years ]
  • Progression-free survival on subsequent therapies [ Time Frame: Up to 15 years ]
  • Site of the metastatic disease and time to progression [ Time Frame: Up to 5 years ]
  • Incidence of treatment related toxicities [ Time Frame: Up to 5 years ]
  • Genetic variance of genes associated with ciclib metabolism [ Time Frame: Up to 5 years ]
  • Quantitative biomarker expressions [ Time Frame: Up to 5 years ]
  • Development of patient-derived models from resistant disease [ Time Frame: Up to 5 years ]
  • Socio-economic features related to the use of ciclibs [ Time Frame: Up to 5 years ]
  • Clinical course of CDK4/6 inhibitor treated patients in the "real-world" setting [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Agnieszka K. Witkiewicz

716-845-1224Agnieszka.Witkiewicz@roswellpark.org

Principal Investigator:

Agnieszka K. Witkiewicz

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2025-11-13.