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Looking for participantsPhase2

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT07405801

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Inavolisib (drug), Ribociclib (drug), Fulvestrant (drug), Placebo (drug)
How long the study runs
Study runs about 46 months (dates as stated)
About the drug or intervention
Inavolisib — drug: Inavolisib will be administered as per the schedule mentioned in the protocol. · Ribociclib — drug: Ribociclib will be administered as per the schedule mentioned in the protocol. · Fulvestrant — drug: Fulvestrant will be administered as per the schedule mentioned in the protocol. · Placebo — drug: Placebo will be administered as per the schedule mentioned in the protocol.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
80
Started
2026-04-07
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • Phase2 - 80 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer

Where?

  • • Leicester - Leicester Royal Infirmary
  • • London - Royal Free Hospital
  • • Manchester - Christie Hospital Nhs Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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).

Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

ERPRstained positivePIK3CA

What the study is looking for

  • ✓Women or men with confirmed by testing a sample carcinoma of the breast that is that has grown locally or...
  • ✓cancer that can be measured on scans per Response Evaluation Criteria in Solid Tumors, Version 1.1 ((standard scan measurements))

Who cannot take part

  • ✗Metaplastic breast cancer
  • ✗Radiotherapy within 2 weeks before randomization
  • ✗Appropriate for treatment with cytotoxic drug treatment at time of entry into the study, as per national or local...
  • ✗Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • ✗Any history of leptomeningeal disease or carcinomatous meningitis
See the full 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)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020) * Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen * Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss) * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Exclusion Criteria: * Metaplastic breast cancer * Radiotherapy within 2 weeks before randomization * Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis) * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible * Any history of leptomeningeal disease or carcinomatous meningitis

Where Is This Study? (3 UK sites)

Leicester Royal Infirmary

Leicester LE1 5WWi, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Christie Hospital Nhs Trust

Manchester M20 4GJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Reference Study ID Number: CO46274 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 global-roche-genentech-trials@gene.com

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10