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Clinical Trial ● Currently Recruiting Phase II NCT07368998

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

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer — Recruiting • Phase II • Oncology • NCT07368998.

📅 14 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase II
NCT ID
NCT07368998
Sponsor
Hoffmann-La Roche
Start
2026-02-18
ClinicaliQ Trial Snapshot
  • To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer — Recruiting • Phase II • Oncology • NCT07368998.
  • What is being tested: Inavolisib (a PI3K inhibitor) combined with fulvestrant (an oestrogen receptor degrader) in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
  • Patient eligibility overview: Adults with advanced or metastatic breast cancer confirmed to have PIK3CA mutations, hormone receptor positivity, and HER2-negativity are eligible for enrolment in this trial.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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.

Eligibility Snapshot
  • : * Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: = 1 study-eligible PIK3CA mutation * Life expectancy of > 6 months * Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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