Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma
Conditions
Brief summary
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre- or post-menopausal HR+ metastatic breast cancer patients who are: * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC). * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC. * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC. * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC. * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.
Exclusion criteria
* Treatment including investigational agent or therapies * Early breast cancer diagnosis * Male breast cancer * Currently receiving treatment for other active malignancy at time of registration * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate) * Inability to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DiviTum®TKa assay as an early predictor of primary treatment resistance | Every cycle (approximately 28 days) until disease progression up to 6 months | Blood samples collected from participants will be assessed using DiviTum®TKa assay for thymidine kinase activity (TKa) levels above Limit of Detection (LOD) as a predictor of primary treatment resistance. Primary treatment resistance will be defined as disease progression in less than 6 months. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORPooja Advani, MBBS, MD
Mayo Clinic
Outcome results
None listed