Clinical trial NCT01220570: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast cancer
ridaforolimus
ridaforolimus/dalotuzumab combination therapy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The population mean change from baseline in GFS (Growth Factor Signature) score
timeFrame: Baseline and Day 15
Secondary outcomes:
measure: The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy
timeFrame: Baseline and Day 15
measure: The correlation between change in Ki67 expression and change in GFS after two weeks of treatment with ridaforolimus/dalotuzumab (MK-8669/MK-0646) combination therapy, ridaforolimus (MK-8669) monotherapy and/or dalotuzumab (MK-0646) monotherapy
timeFrame: Baseline and Day 15
Other outcomes:
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