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Looking for participantsPhase2

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT07368998

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), Fulvestrant (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Inavolisib — drug: Participants will receive Inavolisib as per the schedule given in the protocol. · Fulvestrant — drug: Participants will receive Fulvestrant as per the schedule given 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
2026-02-18
Last checked
2026-10

Plain English Summary

What is this study?

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

Who can take part?

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

Where?

  • • Blackpool - Blackpool Victoria Hospital
  • • Harlow - Princess Alexandra Hospital
  • • Northwood, Middlesex - Mount Vernon Cancer Centre
  • • Oxford - Churchill Hospital - Oxford Cancer & Haematology Centre

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

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.

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

ERHER2PIK3CA

What the study is looking for

  • ✓Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists...
  • ✓Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 ((standard scan measurements))
  • ✓Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic drug treatment is not...
  • ✓Confirmation of test result eligibility: presence of \>= 1 study-eligible PIK3CA mutation
  • ✓Life expectancy of \> 6 months

Who cannot take part

  • ✗Metaplastic breast cancer
  • ✗Prior treatment with drug treatment in the recurrent that has grown locally/that has spread setting
  • ✗Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • ✗Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent that has grown locally/that has spread setting
  • ✗Requirement for daily supplemental oxygen
See the full 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 the locally advanced (recurrent or progressed) or metastatic setting * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Confirmation of biomarker eligibility: presence of \>= 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 Exclusion Criteria: * Metaplastic breast cancer * Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis

Where Is This Study? (4 UK sites)

Blackpool Victoria Hospital

Blackpool FY3 8NR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Princess Alexandra Hospital

Harlow CM20 1QX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Chris Cook

nikki.white6@nhs.net01279 978096

Mount Vernon Cancer Centre

Northwood, Middlesex HA6 2RN, United Kingdom

Recruiting

Churchill Hospital - Oxford Cancer & Haematology Centre

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

How to Get in Touch

Reference Study ID Number: WO46063 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