Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
With
National Cancer Institute (NCI)
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
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
History of metastatic ER negative or HER2 positive breast cancer
Prior treatment in the metastatic setting with everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Uncontrolled symptomatic cardiac arrhythmia
* Uncontrolled hypertension (defined as blood pressure \> 160/90)
Other active second malignancy other than non-melanoma skin cancers =\< 3 years of pre-registration; Note: a second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for =\< 3 years prior to pre-registration
Prior hematopoietic stem cell or bone marrow transplantation =\< 3 years of pre-registration
Known hypersensitivity to palbociclib, letrozole, fulvestrant, goserelin (if applicable) or to any of their excipients
Known to be pregnant and planning to continue nursing
No tumor identified on biopsy or insufficient tumor cells to obtain ER or HER2 status
Any of the following therapies prior to registration:
* Chemotherapy =\< 2 weeks
* Immunotherapy =\< 2 weeks
* Biologic therapy =\< 2 weeks
* Monoclonal antibodies =\< 2 weeks
* Note: Denosumab is exempt from this requirement and can be started at any time prior to initiation of palbociclib and letrozole/fulvestrant without the need to delay protocol therapy
* Radiation therapy =\< 2 weeks
* Note: Palliative radiation therapy to lesions that will not be biopsied for this study or used for assessing disease response (target lesions) is permitted during the pre-registration period and does not count towards the 2 week window
* Anti HER2 or other "targeted" therapy =\< 2 weeks
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception
* Women who have already commenced treatment with an aromatase inhibitor (first line setting) or fulvestrant (second line setting) prior to screening for this study or any prior palbociclib
Clareo Health | Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
