Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02520063
- Run by
- University of Alabama at Birmingham
- People needed
- 15
- Starts
- 2015-02-01
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2026-02-06
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 < 2 (Karnofsky > 60%).
- Must have signed study-specific informed consent.
- Liver Function Tests < 2.5 times the upper normal limit (UNL).
- ANC ≥ 1,500/mm3, platelets ≥ 100,000/mm3, Hemoglobin ≥ 10g%.
- Renal function: serum creatinine < 1.5 institutional UNL or creatinine clearance > 40 cc/min.
You may not qualify if…
- 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.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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