Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage III Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
Conditions
Brief summary
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examining the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
Interventions
PROCEDUREBiopsy
Undergo tumor biopsy
PROCEDUREBiospecimen Collection
Undergo collection of blood, urine, stool, and saliva
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PRE-REGISTRATION INCLUSION CRITERIA * Women who have disease that is amenable to biopsy and agree to undergo a standard of care and /or research biopsy * Note: If a standard of care biopsy was recently obtained =\< 2 months of pre-registration, eligible patients should agree to a research biopsy of recurrent or metastatic breast cancer prior to the start of protocol treatment to collect additional core samples for research purposes * Patients must satisfy one of the following criteria for prior therapy: * First line setting: No prior endocrine therapy in the metastatic setting with no more than one prior line of chemotherapy in the advanced/metastatic setting * Second line setting: Progression on one prior line of endocrine based therapy monotherapy either in the adjuvant or advanced/metastatic setting; either one or two prior lines of chemotherapy in the advanced setting are allowed * Note: Patients receiving bisphosphonate or denosumab therapy prior to registration may continue at the same intervals used prior to study registration * First line therapy setting only: The intention to begin palbociclib and letrozole as treatment for locally advanced or metastatic breast cancer * Second line therapy setting only: The intention to begin palbociclib and fulvestrant as treatment for metastatic breast cancer (after progression on first line endocrine therapy) * Note: Patients who are to receive second line endocrine therapy are allowed to remain on their most recent treatment (tamoxifen or an aromatase inhibitor during the pre-registration period as well as after registration while awaiting insurance approval for the use of palbociclib * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or bone only disease are eligible. * Note: Those patients with both non-measurable disease and bone metastases are eligible * Note: Patients are not allowed to begin a new systemic anti-cancer therapy during pre-registration with the exception of bisphosphonate or denosumab; palliative radiation to lesions that will not be biopsied or used for assessing disease response (target lesions) is allowed during pre-registration * No current evidence of visceral crisis * History of central nervous system metastasis are allowed provided they have been treated (i.e., surgery, radiation, and/or radiosurgery) \>= 12 weeks prior to pre-registration and have stable neurologic function, including no requirement for medication(s) to control symptoms for at least 2 weeks; Note: patients with known leptomeningeal disease are not eligible * Women who are premenopausal must agree to begin or continue an leutinizing hormone releasing hormone (LHRH) agonist (goserelin preferred) * NOTE: A woman is considered premenopausal if menses has occurred in the last 12 months prior to preregistration and both serum and follicle stimulating hormone (FSH) levels are not in the laboratory's reference range for postmenopausal females * Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1, or 2 * Able to swallow oral formulation of drugs * Signed and dated informed consent document for study participation * Willing to submit tissue, blood, stool, and saliva and urine for required correlative research REGISTRATION INCLUSION CRITERIA * Histologic confirmation from the pre-registration biopsy of either locally advanced or metastatic breast cancer that is ER-positive and HER2 -negative * Note: ER-positive disease is defined as \>= 10% nuclear staining; HER2-negative disease per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, one of the following must apply: * 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH) * 0 or 1+ by IHC and ISH not done * 2+ by IHC and not amplified by ISH or * IHC not done and not amplified by ISH * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (=\< 14 days prior to registration) * Platelet count \>= 100,000/mm\^3 (=\< 14 days prior to registration) * Hemoglobin \>= 9.0 g/dL (=\< 14 days prior to registration) * Total bilirubin =\< 1.5 x upper limit of normal (ULN), (=\< 3 x ULN if Gilbert's disease) (=\< 14 days prior to registration) * Aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN if liver metastases present) (=\< 14 days prior to registration) * Creatinine =\< 1.5 x ULN (=\< 14 days prior to registration) * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Toxicities related to all prior anticancer therapies must have resolved or stabilized, apart from alopecia and peripheral neuropathy; Note: Peripheral neuropathy which has resolved to =\< grade 2 toxicity is acceptable
Exclusion criteria
PRE-REGISTRATION
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioinformatics analysis | Up to 3 years | Next-generation sequencing data will be used to identify variants associated with the progression free survival. Pathology analysis will also be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ki67 and TK1 changes | after 2 months of treatment | Spearman rank correlation coefficients will be used to assess the relationship between tumor ki67 levels and serum TK1 levels prior to the start of treatment and after 2 months of treatment with palbocic. |
| Changes in EMT markers (including Vimentin, SLUG and E-cadherin) and tumor infiltrating lymphocytes (TILs) (including CD8, PD-L1, and FOXP3) | after 2 months of treatment | Wilcoxon signed rank tests will be used to assess the fold changes in EMT and TILs after 2 cycles of treatment. Benjamini-Hochberg procedure will be used to control false postive rate. |
| Changes in serum TK1 levels | After 2 months of treatment | Wilcoxon rank sum tests will be used to assess whether a given element of the CD44high/CD24/low/estrogen receptor (ER) low cancer stem cell-like phenotype differ between those whose TK1 levels fell below 200 after 2 cycles of treatment and those whose TK1 levels remained above 200 after 2 cycles of treatment. |
| Change in phenotype of Ki67 and serum TK1 levels | After 2 months of treatment | The parameter estimates from fitting a univariate Cox model to these data will be used to obtain an estimate of the hazard ratio and its corresponding 95% confidence interval. |
| Differences between those with and without a blood draw taken | After 2 months of treatment | A Wilcoxon rank sum test will be used to assess whether baseline TK1 levels differ among those who discontinue treatment prior to the 2 month blood draw and those who do not. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCiara O'Sullivan, M.B., B.Ch.
Mayo Clinic in Rochester
Outcome results
None listed