Molecular Medicine
Conditions
Brief summary
To assess for potential pitfalls and to assess the feasibility of the approach of analysis of new tumor biopsies for selection of standard of care treatment selection in patients with metastatic hormone receptor positive breast cancer who have developed disease progression on 1st line endocrine therapy combined with a CDK4/6 inhibitor.
Detailed description
Primary Objective To assess the feasibility and utility of tumor evaluation to aid in selection of standard of care therapy for patients with hormone receptor positive (HR+) /HER2- advanced/metastatic breast cancer. Secondary Objectives * Accrual Rate (AR) * Clinical Benefit Rate (CBR) * To compare progression free survival (PFS) based on concordance with recommended treatment * Duration of Response (DoR) * Therapy Acceptance Rate (TAR)
Interventions
DEVICEAI and mechanic modeling
The data collected from research tests on your blood and tumor samples will be used to develop an AI model for treatment selection.
Sponsors
Phase One Foundation
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligibility will be evaluated by the study team according to the following criteria. Subjects must meet all of the inclusion and none of the
Exclusion criteria
to be registered to the study. Study treatment may not begin until a subject is registered. * Patients must have histologically confirmed, advanced/unresectable stage III or metastatic hormone receptor positive, HER2 breast cancer. Hormone receptor positive is defined as estrogen receptor \>= 10% and/or progesterone receptor \>=10%. Her2 negative per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines. * Patient must have disease progression during or after CDK4/6 inhibitor (CDK4/6i) combination treatment with an aromatase inhibitor (AI) meeting one of the following criteria. * Disease progression on treatment with a CDK4/6i and AI as 1st line endocrine therapy for advanced/metastatic breast cancer. * Disease progression on or following treatment with a CDK4/6i in the adjuvant setting for early-stage breast cancer. * Age ≥ 18 years. * ECOG performance status of ≤2. * Patient must have at least one lesion amenable to percutaneous core biopsy that is not a purely sclerotic bone lesion. * Patient must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs) | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Outcome results
None listed