A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases

Summary

Purpose: This study is a single-arm, open-label phase II clinical trial testing the hypothesis that daily everolimus plus weekly vinorelbine and trastuzumab will be effective, safe, and tolerable among patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases. Once enrolled, patients will receive everolimus PO daily in combination with weekly intravenous (IV) vinorelbine and trastuzumab. Cycles will be repeated every 3 weeks (21 days). At the time of progression, patients will come off study. Participants: Up to 35 adults over 21 with HER-2 positive breast cancer that has metastasized to the brain.

Timeline

Start

2011-09

Primary completion

2016-08

Completion

2017-10-16

Outcome

Missed primary endpoint

paper Intracranial RR was 4% (1 PR). PMID 29938395 ↗

paper While intracranial RR to ETV was low in HER2 + BCBM patients PMID 29938395 ↗

Publications

• Van Swearingen AED, Siegel MB, Deal AM, Sambade MJ, Hoyle A, Hayes DN, Jo H, Little P, Dees EC, Muss H, Jolly T, Zagar TM, Patel N, Miller CR, Parker JS, Smith JK, Fisher J, Shah N, Nabell L, Nanda R, Dillon P, Abramson V, Carey LA, Anders CK. LCCC 1025: a phase II study of everolimus, trastuzumab, and vinorelbine to treat progressive HER2-positive breast cancer brain metastases. Breast Cancer Res Treat. 2018 Oct;171(3):637-648. doi: 10.1007/s10549-018-4852-5. Epub 2018 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	5 mg	—
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Vinorelbine	Small molecule	25 mg/m2	Intravenous

Indications