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

Sponsor
Hoffmann-La Roche
Study ID
NCT07347600
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inavolisib — DRUG
    Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
  • Palbociclib — DRUG
    Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
  • Fulvestrant — DRUG
    Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Jan 21, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Sep 9, 2029

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Inavolisib
    Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.

Primary Outcome Measure

Real-world Progression-free Survival (rwPFS) [ Time Frame: 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) ]

Central Contacts

  • Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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