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NCT01797120 · ClinicalTrials.gov registry record · Phase 2
Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
A Phase 2 study of Metastatic Breast Cancer, sponsored by PrECOG.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT01797120: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by PrECOG.
NCT01797120 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by PrECOG. The registered enrollment target is 131 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797120, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by PrECOG.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Progression-free survival documented by Physical Exam, CT Scan or MRI in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone from randomization to documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target les
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Everolimus
- DRUG Fulvestrant
Study Locations (20)
Pennsylvania
- Hematology & Oncology Associates of Northeastern PA, PC - Dunmore
- Penn State University - Hershey
- Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- University of Pittsburgh- Magee Women's Hospital - Pittsburgh
- Reading Hospital- McGlinn Family Regional Cancer Center - West Reading
- Main Line Heath System - Wynnewood
California
- Marin Cancer Care - Greenbrae
- Stanford University - Stanford
New York
- Beth Israel - New York
- Montefiore Medical Center - The Bronx
Ohio
- Ohio State University Medical Center - Columbus
- Toledo COP - Toledo
Illinois
- SwedishAmerican Regional Cancer Center - Rockford
Iowa
- McFarland Clinic, PC - Ames
Maryland
- Johns Hopkins University - Baltimore
Michigan
- St. Joseph Mercy Hospital (MI Cancer Consortium) - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2013-05-31 |
| Est. Completion | 2017-09-12 |
| Phase | Phase 2 |
What the finished NCT01797120 record still lists
NCT01797120 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01797120 names 20 study sites across 11 states, led by Pennsylvania, California, New York.
Frequently Asked Questions
What is clinical trial NCT01797120 about?
NCT01797120 is a clinical study titled "Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI". 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 activ...
What is the current status of trial NCT01797120?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2013-05-31. Estimated completion is 2017-09-12.
What conditions does trial NCT01797120 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT01797120?
The interventions under investigation include: Placebo (DRUG), Everolimus (DRUG), Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT01797120?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01797120 being conducted?
This trial has 20 study locations across California, Illinois, Iowa, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01797120's enrollment target sits among peer trials
131 47th of 139 higher than 93 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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