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Oracle Runs

Oracle findings and outcome history for Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer (NCT04544189).

Runs
3
Findings
3
Latest Run
Apr 6, 2026, 2:57 PM
All Oracle Findings

Every stored oracle finding for this trial, including pending, dismissed, rejected, superseded, and accepted items.

NO_DECISIONDismissed85% confidenceGrok 4.20 (xAI)

Will the results be positive?

Trial is active not recruiting with estimated primary completion in Mar 2026. No results, readout, or efficacy statements found for this exact Phase 2 China study (NCT04544189). Other alpelisib + fulvestrant trials (e.g., SOLAR-1) are positive but not this one.

Found Apr 6, 2026, 2:09 PMReviewed Apr 6, 2026, 2:25 PM
Web Searchclinicaltrials.gov
NCT04544189 | Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
Current status: Active Not Recruiting. Estimated Primary Completion: 2026-03-02. No results posted. Phase 2 randomized placebo-controlled study evaluating PFS of alpelisib + fulvestrant vs placebo + fulvestrant.
Web Searchpmc.ncbi.nlm.nih.gov
Expert consensus on the clinical application of PI3K/AKT/mTOR signaling pathway inhibitors in breast cancer
Phase III trial (CBYL719C2201/NCT04544189) on alpelisib plus fulvestrant in Chinese patients ... is still underway.
NO_DECISIONDismissed90% confidencemanual-chat-review

Will the results be positive?

ClinicalTrials.gov still lists this study as active not recruiting with no posted results, so there is not yet a clear public positive or negative trial readout.

Found Apr 4, 2026, 8:54 PMReviewed Apr 4, 2026, 10:32 PM
ClinicalTrialsclinicaltrials.govApr 2, 2026, 12:00 AM
Study Details | NCT04544189 | ClinicalTrials.gov
ClinicalTrials.gov lists active not recruiting; primary completion 2027-01-29; hasResults=false on the latest posted update.
NO_DECISIONDismissed95% confidenceGPT-5.4 (OpenAI)

Will the results be positive?

No trial-specific public efficacy readout was found. The trial record remains active/not recruiting with estimated primary completion on 2026-03-02, and a trial database mirror explicitly shows no results posted. Without a public readout, the outcome cannot be classified positive or negative.

Found Apr 1, 2026, 7:52 PMReviewed Apr 1, 2026, 7:56 PM
ClinicalTrialscdek.pharmacy.purdue.edu
Trial | NCT04544189
Trial mirror lists NCT04544189 as ACTIVE_NOT_RECRUITING, primary completion Mar 02, 2026 (estimated), and states: Study Results — No Results Posted.
Web Searchfdaaa.trialstracker.netOct 21, 2020, 12:00 AM
NCT04544189: An ongoing trial by Novartis Pharmaceuticals
FDAAA TrialTracker labels NCT04544189 an ongoing Novartis Phase 2 trial, supporting that this study has not yet produced a clear posted public results readout.
Outcome History

Public history of accepted oracle reviews and recorded outcome changes for this trial.

No oracle outcome history is available for this trial yet.