Official Title: Combination Treatment With Everolimus Letrozole and Trastuzumab in Hormone Receptor and HER2Neu-Positive Patients With Advanced Metastatic Breast Cancer and Other Solid Tumors Evaluating Synergy and Overcoming Resistance
Status: COMPLETED
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor EGF receptor 2 HER2-positive breast cancer or other solid tumors that have spread to other places in the body Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Estrogen can cause the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by tumor cells Immunotherapy with monoclonal antibodies such as trastuzumab may induce changes in the bodys immune system and may interfere with the ability of tumor cells to grow and spread Giving everolimus letrozole and trastuzumab together may be a better treatment for breast cancer and other solid tumors than everolimus alone
Detailed Description: PRIMARY OBJECTIVES
I Determine reasonable dose of drugs in treatment combination including maximum tolerated dose MTD and toxicity profiles via a brief initial run-indose escalation
II Evaluate response in patients with tumors that demonstrate hormone receptor HR-positivity 1 on immunohistochemistry IHC and human EGF receptor 2 HER-positivity IHC 3 andor IHC 23 and fluorescence in situ hybridization FISH amplification
SECONDARY OBJECTIVES
I Correlate activity of combination with genomic and proteomic signatures II Evaluate 2 expanded cohorts of patients to include 1 HR- and HER2-positive breast cancer n12 and 2 other HR- and HER2-positive tumors that have demonstrated activity in the dose escalation portion of the study n12
OUTLINE This is a dose-escalation study of everolimus and trastuzumab
Patients receive everolimus orally PO once daily QD and letrozole PO QD Patients also receive trastuzumab intravenously IV over 30-90 minutes once every 3 weeks Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 30 days