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Clinical trial · no report yet · Phase 2/Phase 3

INAVO120

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

  • NCT04191499 ↗
  • Active not recruiting
  • Hoffmann-La Roche
  • 225 commentary sources found
  • Deep

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
X threads114
YouTube59
Podcasts49
X videos3

The trial

ClinicalTrials.gov
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Phase
Phase 2/Phase 3
Status
Active not recruiting
Conditions
Breast Cancer
Interventions
Inavolisib; Placebo; Palbociclib; Fulvestrant
Arms
  • Inavolisib + Palbociclib + Fulvestrant · Experimental
  • Placebo + Palbociclib + Fulvestrant · Placebo comparator
Enrollment
325
Primary outcomes
  • Progression-Free Survival (PFS)
Sponsor
Hoffmann-La Roche
Start
Jan 29, 2020
Primary completion
Sep 29, 2023
Results posted
Yes
Registry record
NCT04191499 · updated Sep 11, 2026

Publications

linked from the registry
  • Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31. PubMed 40454641
  • Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625. PubMed 39476340