Inavolisib / Fulvestrant / Breast Cancer · Phase 2 Trial

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

ClinicalTrials.gov · September 4, 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 trial of inavolisib plus fulvestrant in PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer after CDK inhibitor therapy. No results have been posted to this registry record; efficacy, safety, and clinical meaningfulness remain unknown.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer; age from 18 Years. Intervention: Inavolisib Dose A plus Fulvestrant; Inavolisib Dose B plus Fulvestrant. n = 80. 34 sites across 8 countries.

Key findings

Safety

Effect sizes, response rates, adverse event frequencies, and statistical significance are not available.

Who this may help

Until results are published, clinicians cannot assess whether this combination offers efficacy or safety benefits over existing options. The trial is currently recruiting and remains active.

Plain-language summary

This is a Phase 2 interventional trial currently recruiting; no results are posted in this registry record, making it an early-stage study with unknown efficacy and safety outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percentage of Participants With Objective Response Rate (ORR) (assessed at Up to approximately 2 years); Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (assessed at Up to approximately 2 years)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationBreast Cancer; age from 18 Years

Sample size80

InterventionInavolisib Dose A plus Fulvestrant; Inavolisib Dose B plus Fulvestrant

Setting34 sites across 8 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment80

Study phasePhase 2

Primary outcome measure 1Percentage of Participants With Objective Response Rate (ORR), Up to approximately 2 years

Primary outcome measure 2Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Up to approximately 2 years

Clinical bottom line

Until results are published, clinicians cannot assess whether this combination offers efficacy or safety benefits over existing options. The trial is currently recruiting and remains active.

Caveats

No results are reported in this registry record; only study design and planned outcomes are described.
Comparator arm description in the brief summary appears incomplete (states 'compared with inavolisib in combination with fulvestrant' without distinguishing the control).
Recruitment status is ongoing; enrollment has not reached the planned target of 80 participants.
Effect sizes, response rates, adverse event frequencies, and statistical significance are not available.

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

moderate

Phase 2 interventional design; primary outcomes are ORR and TEAEs over ~2 years.

Directness

insufficient

No results posted; cannot assess whether outcomes directly address clinical benefit.

Consistency

insufficient

Single active trial; no comparative efficacy data available in this record.

Risk of bias

insufficient

Recruitment ongoing; study conduct, blinding, and analysis approach not described.

Sample adequacy

limited

Estimated 80 participants planned; typical Phase 2 size, but enrollment not yet complete.

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 (NCT07368998). 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: Fulvestrant. Primary outcome measures: Percentage of Participants With Objective Response Rate (ORR) , Up to approximately 2 years; Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) , Up to approximately 2 years. Brief summary: The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Follow from this

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

NCT07368998InavolisibFulvestrantBreast CancerHoffmann-La Roche