Inavolisib Plus Ribociclib Plus Fulvestrant for Breast Cancer

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

Recruiting Phase 2 Interventional Study
Breast Cancer
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 people with advanced breast cancer that has not responded to hormone treatments. Participants will receive a combination of medications to see how effective they are compared to a placebo.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with breast cancer that has advanced or spread.
  • My breast cancer is estrogen receptor-positive or progesterone receptor-positive.
  • I have not received treatment for metastatic breast cancer before.
  • I experienced disease progression during or within 12 months after hormone therapy.
  • I have confirmed biomarkers from a tumor sample that meet study requirements.
  • I have measurable disease according to specific criteria.

You may not be able to join if

  • I have metaplastic breast cancer.
  • I received radiotherapy in the last 2 weeks.
  • I need chemotherapy based on treatment guidelines.
  • I have type 2 diabetes needing ongoing systemic treatment.
  • I have known active central nervous system metastases.
  • I have a history of leptomeningeal disease or carcinomatous meningitis.

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?

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About This Trial

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-p…
Contacts

Reference Study ID Number: CO46274 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