Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
NCT03439046 · BioItaLEE Phase 3Terminated
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 287 (actual)
- Start date
- 2 Feb 2018
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023
- Last update posted
- 10 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None
- Arms
- 2
Interventions
- Ribociclib Drug
- Letrozole Drug
- Alpelisib Drug
- Fulvestrant Drug
Conditions and primary outcome
- Breast Cancer
Primary outcome
Progression-Free Survival (PFS) by Cycle 1 Day 15 Complete Mutational Dynamic Change (Up to approximately 5.7 years); Number of Participants With Progression-Free Survival (PFS) Events by Cycle 1 Day 15 Complete Mutational Dynamic Change (Up to approximately 5.7 years); Number of Participants With Hotspot Mutated Genes by Scheduled Timepoint (Up to approximately 5.7 years); Percent Change From Screening in Target Mutation Variant Allele Frequency (VAF) (Up to approximately 5.7 years); Number of Participants With Partial Response (PR) in the Extension Phase (Up to approximately 1.6 years)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03439046 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 5.8 years in the core phase and 1.7 years in the extension phase.
| Group | Affected | At risk |
|---|---|---|
| Ribociclib+Letrozole (Core Phase) | 79 | 287 |
| Alpelisib+Fulvestrant (Extension Phase) | 6 | 21 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT03439046.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03439046 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.