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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Ridaforolimus; Drug: Dalotuzumab; Drug: Ridaforolimus + Dalotuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01220570

8669-050

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Ridaforolimus + Dalotuzumab

Experimental group

Description:

Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646)

Treatment:

Drug: Ridaforolimus + Dalotuzumab

Ridaforolimus

Experimental group

Description:

Ridaforolimus (MK-8669)

Treatment:

Drug: Ridaforolimus

Dalotuzumab

Experimental group

Description:

Dalotuzumab (MK-0646)

Treatment:

Drug: Dalotuzumab