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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01220570

Enrollment

Registered

2010-10-14

Start date

2010-09-30

Completion date

2012-12-31

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, ridaforolimus, ridaforolimus/dalotuzumab combination therapy

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.

Interventions

DRUGRidaforolimus + Dalotuzumab

Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks

DRUGRidaforolimus

Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets

DRUGDalotuzumab

Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The population mean change from baseline in GFS (Growth Factor Signature) score	Baseline and Day 15

Secondary

Measure	Time frame
The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy	Baseline and Day 15
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	Baseline and Day 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026