Phase 2
Completed N=15
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
Source: ClinicalTrials.gov NCT02520063 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants Who Experienced Dose-limiting Toxicities — 0; 1 participants
Summary
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-limiting Toxicities |
0; 1 | — |
| SECONDARY Rates of Pathologic Complete Remission (pCR) |
0; 0; 0 | — |
| SECONDARY C Max - Letrozole |
45.3; 41.2; 33.3; 211; 292; 168 | — |
| SECONDARY Tumor Proliferation Changes |
-96.7; 14; -77.8 | — |
| SECONDARY T Max - Letrozole |
3; 1.5; 2 | — |
| SECONDARY AUC - Letrozole |
639; 532; 408; 3500; 2500; 1400 | — |
| SECONDARY T 1/2 - Letrozole |
15.5; 24.7; 31.7 | — |
| SECONDARY C Max - Everolimus |
1.56; 3.7; 2.63; 5.38 | — |
| SECONDARY T Max Everolimus |
2; 1 | — |
| SECONDARY AUC - Everolimus |
15.4; 20.9; 22.5; 32.1 | — |
| SECONDARY T 1/2 - Everolimus |
13.4; 11.8 | — |
Eligibility Criteria
Inclusion Criteria
- Recent diagnosis of hormone receptor positive and HER2 negative breast cancer.
- Stage 2 and 3 hormone receptor positive and HER2 negative breast cancer (stage T2-4 but not inflammatory, N0-2, M0).
- Histological grade I, II or III according to the modified Bloom Richardson scale.
- No prior treatment specific for breast cancer.
- Postmenopausal status as defined by the National Comprehensive Cancer Network.
- ECOG performance status 60%).
- Must have signed study-specific informed consent.
- Liver Function Tests 40 cc/min.
Exclusion Criteria
- Inflammatory breast cancer.
- Pre- and peri-menopausal state.
- Pregnancy.
- Metastatic disease.
- HER2 positive breast cancer by immunohistochemistry or FISH.
- Triple negative breast cancer (hormone receptor and Her2 negative).
- Disease that cannot be followed by imaging studies.
Data sourced from ClinicalTrials.gov (NCT02520063). 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.