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)

A Clinical Trial to Qualify the Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer

This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score among participants with breast cancer.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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