A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS FULVESTRANT VERSUS ALPELISIB PLUS FULVESTRANT IN PATIENTS WITH HORMONE RECEPTOR- POSITIVE, HER2-NEGATIVE, PIK3CA MUTATED, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO PROGRESSED DURING OR AFTER CDK4/6 INHIBITOR AND ENDOCRINE COMBINATION THERAPY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502322-41-00

Acronym

WO43919

Enrollment

150

Registered

2023-06-26

Start date

2023-09-12

Completion date

Unknown

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer

Brief summary

blinded independent central review (BICR-)-assessed progression-free survival (PFS)

Detailed description

Overall survival OS, BICR-assessed Overall Response Rate, BICR-assessed Best Overall Response, BICR-assessed Clinical benefit rate, BICR-assessed Duration of Response, . Time to confirmed a deterioration (TTCD) in pain, TTCD in physical functioning, TTCD in role functioning, TTCD in global health status/QOL, Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) grading scale; treatment discontinuations due to adverse events, Change from baseline in targeted clinical laboratory test results, Plasma concentration of inavolisib at specified timepoints

Interventions

DRUGPiqray 200 mg film-coated tablets

DRUGPiqray 50 mg and 200 mg film-coated tablets

DRUGALPELISIB

DRUGDEXAMETHASONE SODIUM PHOSPHATE

DRUGFULVESTRANT

DRUG-

DRUGINAVOLISIB

DRUGPiqray 150 mg film-coated tablets

DRUGMETFORMIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
blinded independent central review (BICR-)-assessed progression-free survival (PFS)	—

Secondary

Measure	Time frame
Overall survival OS, BICR-assessed Overall Response Rate, BICR-assessed Best Overall Response, BICR-assessed Clinical benefit rate, BICR-assessed Duration of Response, . Time to confirmed a deterioration (TTCD) in pain, TTCD in physical functioning, TTCD in role functioning, TTCD in global health status/QOL, Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) grading scale; treatment discontinuations due to adverse events, Change from baseline in targeted clinical laboratory test results, Plasma concentration of inavolisib at specified timepoints	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026