Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
Public ClinicalTrials.gov record NCT02152943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02152943
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 37 participants
Conditions and interventions
Conditions
- 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
Interventions
- Everolimus Drug
- Laboratory Biomarker Analysis Other
- Letrozole Drug
- Trastuzumab Biological
Drug · Other · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 16, 2014
- Primary completion
- Dec 13, 2020
- Completion
- Dec 13, 2020
- Last update posted
- Dec 18, 2020
2014 – 2020
United States locations
- U.S. sites
- 5
- U.S. states
- 1
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| MD Anderson in Katy | Houston | Texas | 77094 | — |
| MD Anderson League City | Nassau Bay | Texas | 77058 | — |
| MD Anderson in Sugar Land | Sugar Land | Texas | 77478 | — |
| MD Anderson in The Woodlands | The Woodlands | Texas | 77384 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02152943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2020 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02152943 live on ClinicalTrials.gov.