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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (6 UK sites)
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
Blackpool Victoria Hospital
Blackpool FY3 8NR, United Kingdom
Colchester General Hospital
Colchester, Essex CO4 5JL, United Kingdom
Mount Vernon Hospital
Northwood HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
Churchill Hospital
Oxford OX3 7LJ, United Kingdom
How to Get in Touch
Reference Study ID Number: WO44263 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
