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NCT01698918 · ClinicalTrials.gov registry record · Phase 2
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
NCT01698918: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01698918 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 202 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01698918, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
Study Summary
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.
Primary Outcome
PFS in the first line setting is defined as the time from the date of enrollment to the date of first documented progression based on local radiology review or death due to any cause. If a participant did not progress or was not known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. The median PFS was estimated and presented
Interventions
- DRUG Letrozole
- DRUG Exemestane
- DRUG Everolimus
- DRUG Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study)
- DRUG Standard of care to treat stomatitis (Stomatitis sub-study)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2013-03-07 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 2 |
What the finished NCT01698918 record still lists
NCT01698918 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT01698918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01698918 about?
NCT01698918 is a clinical study titled "Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer". 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...
What is the current status of trial NCT01698918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2013-03-07. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT01698918?
The interventions under investigation include: Letrozole (DRUG), Exemestane (DRUG), Everolimus (DRUG), Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study) (DRUG), Standard of care to treat stomatitis (Stomatitis sub-study) (DRUG).
Who is sponsoring clinical trial NCT01698918?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01698918's enrollment target sits among peer trials
202 301st of 2000 higher than 1,699 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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