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Looking for participantsPhase3

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Sponsor: Hoffmann-La Roche

NCT ID: NCT05894239

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), Phesgo (drug), Placebo (drug), Taxane-based Chemotherapy (drug)
How long the study runs
Study runs about 111 months (dates as stated)
About the drug or intervention
Inavolisib — drug: Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment. · Phesgo — drug: Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle. · Placebo — drug: Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment. · Taxane-based Chemotherapy — drug: During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo. · Optional Endocrine Therapy of Investigator's Choice — drug: Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
230
Started
2023-09-08
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic breast cancer
  • • Phase3 - 230 participants
  • • This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC)

Who can take part?

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

Where?

  • • Belfast - Belfast City Hospital
  • • Blackpool - Blackpool Victoria Hospital
  • • Colchester, Essex - Colchester General Hospital
  • • Northwood - Mount Vernon Hospital
  • • +2 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 inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Metastatic 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

HER2PIK3CA

What the study is looking for

  • ✓activity scale (ECOG) Performance Status 0 or 1
  • ✓confirmed by testing a sample and documented adenocarcinoma of the breast with that has spread or locally...
  • ✓Confirmation of HER2 test result eligibility based on valid results from central testing of tumor tissue documenting...
  • ✓Confirmation of PIK3CA-mutation test result eligibility based on valid results from central testing of tumor tissue...
  • ✓Disease-free interval from completion of after surgery or before surgery systemic non-hormonal treatment to recurrence of...

Who cannot take part

  • ✗Prior treatment in the that has grown locally or that has spread setting with any PI3K, AKT, or mTOR inhibitor or any agent...
  • ✗Any prior systemic non-hormonal anti-cancer therapy for that has grown locally or that has spread HER2-positive breast cancer...
  • ✗History or active inflammatory bowel disease
  • ✗Disease progression within 6 months of receiving any HER2-treatment that targets specific changes in the cancer
  • ✗Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
See the full criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection * Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity * Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status * Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \>= 6 months * LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria: * Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway * Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy * History or active inflammatory bowel disease * Disease progression within 6 months of receiving any HER2-targeted therapy * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Participants with active HBV infection * Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis * Symptomatic active lung disease, including pneumonitis or interstitial lung disease * Any history of leptomeningeal disease or carcinomatous meningitis * Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1 * Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

Where Is This Study? (6 UK sites)

Belfast City Hospital

Belfast BT9 7AB, United Kingdom

WITHDRAWN

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

Mount Vernon Hospital

Northwood HA6 2RN, United Kingdom

Recruiting

Nottingham City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Churchill Hospital

Oxford OX3 7LJ, United Kingdom

Recruiting

How to Get in Touch

Reference Study ID Number: WO44263 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: 2026-09