Ribociclib / Inavolisib / Fulvestrant · Phase 2 Trial

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 2 randomized trial comparing inavolisib plus ribociclib plus fulvestrant to placebo plus ribociclib plus fulvestrant in treatment-naïve HR+/HER2− advanced breast cancer. No results are posted in this registry record; the trial is currently recruiting and efficacy and safety data have not yet been reported.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Breast Cancer; age from 18 Years. Intervention: Inavolisib + Ribociclib + Fulvestrant. Compared with: Placebo + Ribociclib + Fulvestrant — Placebo Comparator. n = 80. 54 sites across 12 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported. No data on response rate, progression-free survival, overall survival, or adverse events are provided.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an actively recruiting Phase 2 trial with no results posted; the registry record describes design and planned endpoints only, not outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Percentage of Participants With Confirmed Objective Response (cORR) (assessed at Up to approximately 2 years)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationBreast Cancer; age from 18 Years

Sample size80

InterventionInavolisib + Ribociclib + Fulvestrant

ComparatorPlacebo + Ribociclib + Fulvestrant — Placebo Comparator

Setting54 sites across 12 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment80

PhasePhase 2

Primary endpointPercentage of Participants With Confirmed Objective Response (cORR), up to approximately 2 years

Caveats

This is a registry record only; no efficacy or safety results are reported.
Results have not been posted; trial is actively recruiting.
No data on response rate, progression-free survival, overall survival, or adverse events are provided.
Study design details such as randomisation method, blinding procedure, and statistical analysis plan are not fully described in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized controlled trial with active comparator and blinding structure.

Directness

strong

Clinical efficacy and safety endpoints in advanced breast cancer population.

Consistency

insufficient

No results reported; consistency cannot be assessed against other trials.

Risk of bias

insufficient

Registry record does not detail methods for blinding, randomisation, or outcome ascertainment.

Sample adequacy

limited

Planned enrollment of 80 participants is modest for Phase 2 efficacy claim.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07405801). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DRUG: Inavolisib; DRUG: Ribociclib; DRUG: Fulvestrant; DRUG: Placebo. Primary outcome measures: Percentage of Participants With Confirmed Objective Response (cORR) , Up to approximately 2 years. Brief summary: A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

RibociclibNCT07405801InavolisibFulvestrantBreast CancerHoffmann-La Roche