A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)
Source: ClinicalTrials.gov NCT01605396 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) |
23.29; 31.86 | 0.565 |
| SECONDARY Percent Change From Baseline in Sum of Target Lesion Diameters at Week 16 |
-19.3; -10.7 | — |
| SECONDARY 3. Percentage of Participants With Objective Response (Objective Response Rate [ORR]) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR). |
15.0; 25.0 | 0.267 |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.562 |
Eligibility Criteria
Inclusion Criteria
- Females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to
surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and Human Epidermal Growth Factor Receptor 2 (HER-2) negative, and Ki67 (a tumor marker) ≥ 15% determined by the central study laboratory
- Post-menopausal
- With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
- Has at least one confirmed measurable metastatic lesion
- Has a performance status ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- Has a life expectancy of at least 3 months
- Adequate organ function
Exclusion Criteria
- Is receiving any other concurrent systemic tumor therapy, including
hormonal agents and HER-2 inhibitors
- Previously received rapamycin or rapamycin analogs, including
ridaforolimus, temsirolimus, or everolimus
- Received prior treatment with Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors, Phosphatidylinositol 3-Kinase (PI3K) inhibitors, or
other experimental agents that target PI3K, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway
- Is receiving chronic corticosteroids administered at doses greater than
those used for normal replacement therapy
- Has active brain metastasis or leptomeningeal carcinomatosis; patients
with adequately treated brain metastases are eligible if they meet certain criteria
- Known allergy to macrolide antibiotics
- Has an active infection requiring antibiotics
- Significant or uncontrolled cardiovascular disease
- Poorly controlled Type 1 or 2 diabetes
- Is known to be Human Immunodeficiency Virus (HIV) positive
- Has a known history of active hepatitis B or C. Healthy carriers of hepatitis B are not allowed on this study
Data sourced from ClinicalTrials.gov (NCT01605396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.