Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
Public ClinicalTrials.gov record NCT01698918. 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
An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.
Study identification
- NCT ID
- NCT01698918
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 202 participants
Conditions and interventions
Conditions
Interventions
- Everolimus Drug
- Letrozole Drug
- Exemestane Drug
- Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study) Drug
- Standard of care to treat stomatitis (Stomatitis sub-study) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Mar 7, 2013 (Actual)
- Primary completion
- Dec 17, 2015 (Actual)
- Completion
- Jan 13, 2021 (Actual)
- Last update posted
- May 3, 2023
2013 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center SC-2 | Birmingham | Alabama | 35294 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Loma Linda University Loma Linda | Loma Linda | California | 92354 | — |
| Breastlink Medical Group Dept. of BreastlinkResearchGrp | Long Beach | California | 90806 | — |
| Oncology Specialists, SC Advocate Medical Group-Niles | Park Ridge | Illinois | 60068-0736 | — |
| St. Francis Health Comprehensive Cancer Center | Topeka | Kansas | 66606-169 | — |
| Norton Healthcare Inc SC | Louisville | Kentucky | 40202 | — |
| Baystate Medical Center SC-2 | Springfield | Massachusetts | 01199 | — |
| Saint Barnabas Medical Center CancerCenter of Saint Barnabas | Livingston | New Jersey | 07039 | — |
| University of New Mexico Hospital SC | Albuquerque | New Mexico | 87106 | — |
| Broome Oncology SC | Johnson City | New York | 13790 | — |
| Columbia University Medical Center- New York Presbyterian Columbia | New York | New York | 10032 | — |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | — |
| East Texas Hematology Clinic SC | Lufkin | Texas | 75904 | — |
| Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City | Utah | 84106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01698918, 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 May 3, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01698918 live on ClinicalTrials.gov.