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Looking for participantsPhase3

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Sponsor: Hoffmann-La Roche

NCT ID: NCT06790693

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), Placebo (drug), CDK4/6i (drug), Letrozole (drug)
How long the study runs
Study runs about 82 months (dates as stated)
About the drug or intervention
Inavolisib — drug: Participants will receive oral inavolisib once daily (QD). · Placebo — drug: Participants will receive oral placebo QD. · CDK4/6i — drug: Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle. · Letrozole — drug: Participants will receive oral letrozole QD.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
450
Started
2025-04-09
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • Phase3 - 450 participants
  • • This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-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?

  • • Blackpool - Blackpool Victoria Hospital
  • • Colchester, Essex - Colchester General Hospital
  • • Edinburgh - Western General Hospital
  • • Harlow - Princess Alexandra Hospital
  • • +5 more UK sites

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

About This Trial

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-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

ERHER2

What the study is looking for

  • ✓Women or men with confirmed by testing a sample carcinoma of the breast
  • ✓Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical...
  • ✓Documented HER2-negative tumor according to ASCO/CAP guidelines
  • ✓Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
  • ✓Confirmation of test result eligibility

Who cannot take part

  • ✗Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which...
  • ✗Metaplastic breast cancer
  • ✗Any prior treatment that goes through your whole body for that has grown locally unresectable or that has spread breast cancer
  • ✗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 * Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Documented HER2-negative tumor according to ASCO/CAP guidelines * De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment * Participants who have bilateral breast cancers which are both HR-positive and HER2-negative * Confirmation of biomarker eligibility * Consent to provide fresh or archival tumor tissue specimen * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and organ function within 14 days prior to initiation of study treatment Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Metaplastic breast cancer * Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer * 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 * Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye * Symptomatic active lung disease * History of or active inflammatory bowel disease * Any active bowel inflammation * Prior hematopoietic stem cell or bone marrow transplantation * Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

Where Is This Study? (9 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

Colchester General Hospital

Colchester, Essex CO4 5JL, United Kingdom

Recruiting

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Princess Alexandra Hospital

Harlow CM20 1QX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Chris Cook

nikki.white6@nhs.net01279 978096

St Bartholomew's Hospital

London EC1M 6BQ, United Kingdom

Recruiting

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Mount Vernon & Watford Hospital Trust

Northwood 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---

Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: WO45654 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. Only) 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