inavolisib: Clinical Trials

4 recruiting, 1 active not recruiting. 5 Phase 3, 1 Phase 2.

By phase and status

Phase	Trials	Status
Phase 3	5	Recruiting 4, Active not recruiting 1
Phase 2	1	Active not recruiting 1

Follow inavolisib: new trials by email Literature Review of inavolisib trials Research Report on inavolisib

Trials (filtered) newest first · largest first

All 5 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Inavolisib, Placebo, CDK4/6i - Breast Cancer	Phase 3	Recruiting	Hoffmann-La Roche	450	2025-04-09	2026-11-04
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer Inavolisib, Phesgo, Placebo - Metastatic Breast Cancer	Phase 3	Recruiting	Hoffmann-La Roche	230	2023-09-08	2026-11-13
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy Inavolisib, Fulvestrant, Alpelisib - Breast Cancer	Phase 3	Recruiting	Hoffmann-La Roche	420	2023-06-07	2026-10-26
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study Ipatasertib, Tiragolumab, Atezolizumab - Cancer	Phase 3	Recruiting	Hoffmann-La Roche	200	2023-06-01	2026-11-06
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 Inavolisib, Placebo, Palbociclib - Breast Cancer	Phase 2 / Phase 3	Active not recruiting	Hoffmann-La Roche	325	2020-01-29	2026-09-11

Conditions studied

Breast Neoplasms (4)  ·  Neoplasms (1)

Sponsors

Hoffmann-La Roche (5)

Countries

Canada (5)  ·  China (5)  ·  France (5)  ·  Poland (5)  ·  South Korea (5)  ·  Taiwan (5)  ·  United Kingdom (5)  ·  Argentina (4)  ·  Australia (4)  ·  Belgium (4)  ·  Brazil (4)  ·  Germany (4)  ·  Italy (4)  ·  Mexico (4)  ·  Spain (4)

Results publications

PMID 39476340, PMID 40454641

NIH funding

2023 (2), 2019 (1)