Clinical trial · Interventional
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
NCT01220570CI-TRIAL-00016662completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalotuzumab | Drug | — | UNRESOLVED |
| Ridaforolimus | Drug | Ridaforolimus | ALIAS |
| Ridaforolimus + Dalotuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ridaforolimus + Dalotuzumab
- description
- Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646)
- interventionNames
- Drug: Ridaforolimus + Dalotuzumab
- type
- EXPERIMENTAL
- label
- Ridaforolimus
- description
- Ridaforolimus (MK-8669)
- interventionNames
- Drug: Ridaforolimus
- type
- EXPERIMENTAL
- label
- Dalotuzumab
- description
- Dalotuzumab (MK-0646)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.