Clinical trial · Interventional
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
A Phase I/II Study of Preoperative (Neoadjuvant) Combination of Letrozole (Femara), Everolimus (Afinitor), and TRC105 in Postmenopausal Women With Newly Diagnosed Local or Locally Advanced Potentially Resectable Hormone-Receptor Positive and Her2 Negative Breast Cancer
- 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 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.
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 |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| TRC105 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase I Cohort 1
- description
- Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks
- interventionNames
- Drug: Letrozole
- Drug: Everolimus
- Drug: TRC105
- type
- EXPERIMENTAL
- label
- Phase I Cohort 2
- description
- Letrozole 2.5 mg PO daily until surgery, everolimus 10 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks
- interventionNames
- Drug: Letrozole
- Drug: Everolimus
- Drug: TRC105
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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 \< 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. 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.
References
Publications (1)
- DERIVEDVaklavas C, Stringer-Reasor EM, Elkhanany AM, Ryan KJ, Li Y, Theuer CP, Acosta EP, Wei S, Yang ES, Grizzle WE, Forero-Torres A. A phase I/II study of preoperative letrozole, everolimus, and carotuximab in stage 2 and 3 hormone receptor-positive and Her2-negative breast cancer. Breast Cancer Res Treat. 2023 Apr;198(2):217-229. doi: 10.1007/s10549-023-06864-9. Epub 2023 Feb 3. PMID 36735117