Clareo Health | The Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer (MK-8669-050)
The Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer (MK-8669-050)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Participant has operable Stage I-IIIa invasive breast cancer of the following subtype: ER-positive, HER2-negative tumor with histologic grade 2 or 3 and Ki67 ≥ 15%
Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
Participant consents to provide an existing tissue sample or to have a core needle biopsy before drug administration
Participant consents to provide tissue samples following drug administration by a second core needle biopsy or from a surgical specimen
Participant must have adequate organ function
You may not be if
Participant has received any prior chemotherapy, biological therapy or radiotherapy for breast cancer
Participant has a known hypersensitivity to the components of study drugs or their analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin, erythromycin, azithromycin).
Participant has poorly controlled diabetes mellitus, or requires insulin for glucose control.
Participant is unable to swallow capsules and/or absorb oral medications
Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
Participant is known to be Human Immunodeficiency Virus (HIV)-positive
Participant has known history of active Hepatitis B or C.
Participant is concurrently using growth hormone (GH) or growth hormone inhibitors
Participant has significant or uncontrolled cardiovascular disease, including heart failure, unstable angina, or a myocardial infarction within the last 6 months
