Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
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|ClinicalTrials.gov Identifier: NCT02152943|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Estrogen Receptor Positive HER2/Neu Positive Postmenopausal Premenopausal Progesterone Receptor Positive Recurrent Breast Carcinoma Refractory Breast Carcinoma Refractory Hormone Receptor Positive Breast Carcinoma Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7||Drug: Everolimus Other: Laboratory Biomarker Analysis Drug: Letrozole Biological: Trastuzumab||Phase 1|
I. Determine reasonable dose of drugs in treatment combination, including maximum tolerated dose (MTD) and toxicity profiles, via a brief initial "run-in"/dose 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 and/or IHC 2/3 and fluorescence in situ hybridization [FISH] amplification).
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 (n=12) and 2) other HR- and HER2-positive tumors that have demonstrated activity in the dose escalation portion of the study (n=12).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Treatment With Everolimus, Letrozole and Trastuzumab in Hormone Receptor and HER2/Neu-Positive Patients With Advanced Metastatic Breast Cancer and Other Solid Tumors: Evaluating Synergy and Overcoming Resistance|
|Actual Study Start Date :||July 17, 2014|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: Treatment (everolimus, letrozole, trastuzumab)
Patients receive everolimus PO QD and letrozole PO QD. Patients also receive trastuzumab IV over 30-90 minutes once every 3 weeks. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose and/or recommended phase II dose [ Time Frame: 21 days ]Defined as the highest dose at which no more than 1 of 6 patients has had dose-limiting toxicity.
- Clinical benefit rate [ Time Frame: Up to 4 years ]Defined as the percentage of patients with stable disease >= 6 months/partial response/complete response. The point estimate and the 90% exact confidence interval for the clinical benefit rate will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152943
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|MD Anderson in Katy|
|Houston, Texas, United States, 77094|
|MD Anderson League City|
|Nassau Bay, Texas, United States, 77058|
|MD Anderson in Sugar Land|
|Sugar Land, Texas, United States, 77478|
|MD Anderson in The Woodlands|
|The Woodlands, Texas, United States, 77384|
|Principal Investigator:||Filip Janku||M.D. Anderson Cancer Center|