Palbociclib / Metastatic Breast Cancer / Locally Advanced Breast Cancer · Observational Study

A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic 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 observational study registered on ClinicalTrials.gov evaluating real-world effectiveness of inavolisib-based regimens in PIK3CA-mutated, endocrine-resistant HR+/HER2− advanced breast cancer in China. No results are currently available in this registry record.

What was studied

Observational. Locally Advanced Breast Cancer, Metastatic Breast Cancer; age from 18 Years. Intervention: Inavolisib. n = 500. 29 sites: China.

Key findings

Safety

This is a registry record with no results reported; no efficacy, safety, or outcome data are available

Who this may help

This study will provide real-world evidence on inavolisib effectiveness in a molecularly defined breast cancer population, but results are not yet available and observational design limits causal inference. Clinicians should await completion and peer-reviewed publication.

Plain-language summary

This is an active observational registry study with no reported results; it describes a planned real-world effectiveness evaluation in a specific population but carries no outcome data.

Study design

As stated by the source record.

MethodsCohort model. Other time perspective. Primary outcome measure: Real-world Progression-free Survival (rwPFS) (assessed at From index date (date of first prescription of inavolisib) to first occurrence…)

DesignObservational

PopulationLocally Advanced Breast Cancer, Metastatic Breast Cancer; age from 18 Years

Sample size500

InterventionInavolisib

Setting29 sites: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Primary outcome measureReal-world Progression-free Survival (rwPFS) from index date to first PD/death, up to approximately 36 months

Study typeObservational

Recruitment statusRECRUITING

Clinical bottom line

Caveats

This is a registry record with no results reported; no efficacy, safety, or outcome data are available
Observational design without randomization or control arm limits ability to establish comparative effectiveness
No information provided on study completion date, interim analyses, or expected reporting timeline
Real-world setting in China may have limited generalizability to other health-care systems

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

limited

Observational design without randomization or control arm comparator

Directness

strong

Real-world progression-free survival directly measures clinical effectiveness

Consistency

insufficient

No results reported; consistency cannot be assessed

Risk of bias

limited

Observational design without blinding; confounding and selection bias possible

Sample adequacy

moderate

Planned enrollment 500 participants; adequacy depends on outcome frequency

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 (NCT07347600). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer. Interventions: DRUG: Inavolisib; DRUG: Palbociclib; DRUG: Fulvestrant. Primary outcome measures: Real-world Progression-free Survival (rwPFS) , From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months). Brief summary: The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

Follow from this

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

PalbociclibNCT07347600Metastatic Breast CancerLocally Advanced Breast CancerInavolisibFulvestrantHoffmann-La Roche