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NCT07054190 · ClinicalTrials.gov registry record · Phase 2

A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

A Phase 2 study, sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target

NCT07054190: Recruiting Phase 2 study, sponsored by Hoffmann-La Roche.

NCT07054190 is a Phase 2 study that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07054190, a Phase 2 study, is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

Interventions

  • DRUG Letrozole
  • DRUG Ribociclib
  • DRUG Inavolisib

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-09-09
Est. Completion 2027-09-28
Phase Phase 2
Hoffmann-La Roche

909 total trials

What NCT07054190 shows while recruiting

NCT07054190 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 3 interventions - of which Letrozole is the first listed.

NCT07054190 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07054190 about?

NCT07054190 is a clinical study titled "A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer". This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).

What is the current status of trial NCT07054190?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-09-09. Estimated completion is 2027-09-28.

What interventions are being tested in trial NCT07054190?

The interventions under investigation include: Letrozole (DRUG), Ribociclib (DRUG), Inavolisib (DRUG).

Who is sponsoring clinical trial NCT07054190?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07054190's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07054190, the US trial registry maintained by the National Library of Medicine. NCT07054190 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.