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Inavolisib and Fulvestrant for Breast Cancer

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

Recruiting Phase 2 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for

This trial is looking for adults with a specific type of breast cancer who have had treatment before. Participants will take a combination of two medications and help researchers understand their effects.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with breast cancer
  • I have a PIK3CA mutation
  • I have had disease progression after treatment with a CDK4/6 inhibitor
  • I have not had more than 1 prior line of systemic therapy
  • I can complete study-related procedures
  • My doctor thinks I should receive endocrine-based therapy
  • My life expectancy is more than 6 months

You may not be able to join if

  • I have metaplastic breast cancer
  • I have had chemotherapy for advanced breast cancer
  • I have type 1 diabetes
  • I need daily supplemental oxygen
  • I have active lung disease or pneumonitis
  • I am being treated for type 2 diabetes

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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.

Trial Locations

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Eligibility Criteria
Inclusion Criteria: * 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 prior lines of systemic therapy in …
Contacts

Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.

888-662-6728

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

NCT ID: NCT07368998 Source: ClinicalTrials.gov