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NCT02152943 · ClinicalTrials.gov registry record · Phase 1
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
A Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 5
- Study locations
NCT02152943 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 37 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT02152943, a Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Breast Carcinoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 5
- Study locations
Study 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 body's 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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Letrozole
- DRUG Everolimus
- BIOLOGICAL Trastuzumab
Study Locations (5)
Texas
- M D Anderson Cancer Center - Houston
- MD Anderson in Katy - Houston
- MD Anderson League City - Nassau Bay
- MD Anderson in Sugar Land - Sugar Land
- MD Anderson in The Woodlands - The Woodlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-07-17 |
| Est. Completion | 2020-12-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02152943
The ClinicalTrials.gov registry entry for NCT02152943 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (79% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02152943 reports 5 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02152943 about?
NCT02152943 is a clinical study titled "Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients". 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 ot...
What is the current status of trial NCT02152943?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2014-07-17. Estimated completion is 2020-12-14.
What conditions does trial NCT02152943 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Recurrent Breast Carcinoma, Estrogen Receptor Positive, Postmenopausal, Stage IIIA Breast Cancer AJCC v7.
What interventions are being tested in trial NCT02152943?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Letrozole (DRUG), Everolimus (DRUG), Trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02152943?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02152943 being conducted?
This trial has 5 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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