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)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antibodies, Monoclonal; Mitogens; Sirolimus

Criteria

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