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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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 202 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01698918
The ClinicalTrials.gov registry entry for NCT01698918 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT01698918 reports 0 study locations.
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.
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