Clinical trial NCT04526587: Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4/6 Inhibitors
Official title: The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with estrogen receptor positive (ER+)/HER2 negative (-) metastatic breast cancer, who are being or have been treated with ciclib-based therapies

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.

Detailed description: PRIMARY OBJECTIVES:

I. Delineate clinical features of disease progression and responses to subsequent therapy following progression on ciclib-based therapy.

II. Define pharmacogenomics relationships that could provide a more precise approach to drug dosing.

III. Interrogate biomarkers related to response and acquired resistance in standard clinical practice.

IV. Develop patient-derived models from resistant disease to functionally assess the mechanisms occurring with resistance.

V. Elucidate the socio-demographic features related to the use of ciclibs clinically in the Roswell Park catchment area.

OUTLINE:

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.

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

Primary outcomes:
measure: Collection of clinical characteristics
timeFrame: Up to 5 years
measure: Overall survival on ciclib
timeFrame: Up to 15 years
measure: Progression-free survival on ciclib
timeFrame: Up to 15 years
measure: Progression-free survival on subsequent therapies
timeFrame: Up to 15 years
measure: Site of the metastatic disease and time to progression
timeFrame: Up to 5 years
measure: Incidence of treatment related toxicities
timeFrame: Up to 5 years
measure: Genetic variance of genes associated with ciclib metabolism
timeFrame: Up to 5 years
measure: Quantitative biomarker expressions
timeFrame: Up to 5 years
measure: Development of patient-derived models from resistant disease
timeFrame: Up to 5 years
measure: Socio-economic features related to the use of ciclibs
timeFrame: Up to 5 years
measure: Clinical course of CDK4/6 inhibitor treated patients in the "real-world" setting
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
measure: Examination of biomarkers of response
timeFrame: Up to 5 years
measure: Single-nucleotide polymorphisms
timeFrame: Day 8 to day 18 of cycle 1
measure: Circulating cell free DNA (cfDNA)
timeFrame: Up to 5 years
measure: Development of functional models (patient-derived models) from individuals with progressive disease
timeFrame: Up to 5 years
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Agnieszka K Witkiewicz
role: PRINCIPAL_INVESTIGATOR
References: