Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
Public ClinicalTrials.gov record NCT01797120. 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
Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) Plus Everolimus in Post-Menopausal Patients With Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients). Fulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy. Everolimus is an orally administered drug that blocks a signaling pathway called "mTOR". "mTOR" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth. The combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.
Study identification
- NCT ID
- NCT01797120
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 131 participants
Conditions and interventions
Conditions
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
- May 31, 2013 (Actual)
- Primary completion
- Mar 22, 2017 (Actual)
- Completion
- Sep 12, 2017 (Actual)
- Last update posted
- May 30, 2018
2013 – 2017
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| Stanford University | Stanford | California | 94305 | — |
| SwedishAmerican Regional Cancer Center | Rockford | Illinois | 61104 | — |
| McFarland Clinic, PC | Ames | Iowa | 50010-3014 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| St. Joseph Mercy Hospital (MI Cancer Consortium) | Ann Arbor | Michigan | 48158 | — |
| Metro MN | Saint Louis Park | Minnesota | 55416 | — |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | — |
| Beth Israel | New York | New York | 10011 | — |
| Montefiore Medical Center | The Bronx | New York | 10466 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Toledo COP | Toledo | Ohio | 43617 | — |
| Hematology & Oncology Associates of Northeastern PA, PC | Dunmore | Pennsylvania | 18512 | — |
| Penn State University | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh- Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Reading Hospital- McGlinn Family Regional Cancer Center | West Reading | Pennsylvania | 19611 | — |
| Main Line Heath System | Wynnewood | Pennsylvania | 19096 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
| Charleston Area Medical Center (CAMC) | Charleston | West Virginia | 25304 | — |
| St. Vincent Hospital | Green Bay | Wisconsin | 54301 | — |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | — |
| ProHealth Care Inc. (Waukesha) | Waukesha | Wisconsin | 53188 | — |
| Aurora Cancer Care | Wauwatosa | Wisconsin | 53226 | — |
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 NCT01797120, 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 30, 2018 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01797120 live on ClinicalTrials.gov.