Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01220570
Start Date
September 1 2010
End Date
December 1 2012
Last Update
January 21 2015
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