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
- Capecitabine (drug), Atezolizumab (drug), Ipatasertib (drug), SGN-LIV1A (drug)
- How long the study runs
- Study runs about 150 months (dates as stated)
- About the drug or intervention
- Capecitabine — drug: Capecitabine will be administered 1250 milligrams per square meter (mg/m\^2) orally twice daily on Days 1-14 of each 21-day cycle. · Atezolizumab — drug: For Atezolizumab + SGN-LIV1A, Atezolizumab + Sacituzumab Govitecan, or Atezolizumab + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle. · Ipatasertib — drug: Ipatasertib will be administered by mouth 400 mg once a day, on Days 1-21 of each 28-day cycle. · SGN-LIV1A — drug: SGN-LIV1A will be administered IV, 2.5 milligrams per kilogram (mg/kg) (maximum calculated dose 250 mg), on Day 1 of each 21-day cycle. · Bevacizumab — drug: Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28-day cycle. · Chemotherapy (Gemcitabine + Carboplatin or Eribulin) — drug: Gemcitabine will be administered by IV, 1000 mg/m\^2, along with carboplatin, by IV, on Days 1 and 8 of each 21-day cycle. · Selicrelumab — drug: Selicrelumab will be administered by subcutaneous (SC) injection, at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (Cycle = 28 days). · Tocilizumab — drug: Tocilizumab will be administered IV, 8 mg/kg on Day 1 of each 28-day cycle. · Nab-Paclitaxel — drug: Nab-Paclitaxel will be administered IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle. · Sacituzumab Govitecan — drug: Sacituzumab govitecan will be administered by IV infusion, 10 mg/kg, on Days 1 and 8 of each 21-day cycle. · Abemaciclib — drug: Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each 28-day cycle. · Fulvestrant — drug: For Inavolisib + Abemaciclib + Fulvestrant, Inavolisib + Ribociclib (Dose #1) + Fulvestrant, Inavolisib + Ribociclib (Dose #2) + Fulvestrant, or Inavolisib + Atirmociclib + Fulvestrant arms: Fulvestrant 500 mg, administered as an IM injection on Days 1 and 15 of Cycle 1, followed by Day 1 of each 28-day cycle thereafter. · Ribociclib (Dose #1) — drug: Ribociclib tablets will be administered by mouth once daily. · Inavolisib (Dose #1) — drug: Inavolisib tablets will be administered by mouth once daily. · Trastuzumab Deruxtecan — drug: Trastuzumab Deruxtecan will be administered IV, 5.4 mg/kg on Day 1 of each 21-day cycle. · Ribociclib (Dose #2) — drug: Ribociclib tablets will be administered by mouth once daily. · Letrozole — drug: Letrozole tablets will be administered at a dose of 2.5 mg once a day by mouth on Days 1-28 of each 28-day cycle. · Inavolisib (Dose #2) — drug: Inavolisib tablets will be administered by mouth OD. · Empagliflozin — drug: Empagliflozin, administered orally, once daily (QD) · Palbociclib — drug: For Empagliflozin + Inavolisib + Fulvestrant ± Palbociclib arm: Palbociclib 125 mg administered orally, QD in Cycle 1 followed by 125 mg on Days 1-21 of each cycle. · Metformin — drug: Metf 1000 mg administered orally QD. · Atirmociclib — drug: Atirmociclib administered orally, BID on Days 1-28 for each 28-day cycle. · Giredestrant — drug: Giredestrant 30 mg will be administered by mouth once daily, on Days 1-28 of each 28-day cycle.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,132
- Started
- 2018-03-30
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic breast cancer
- • Phase1/Phase2 - 1,132 participants
- • This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic breast cancer
Where?
- • Glasgow - Beatson West of Scotland Cancer Centre
- • London - Barts Health NHS Trust - St Bartholomew's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naïve cohort). Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
How this trial compares with your answers
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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
Treatment history
Treatments you must have had:
- ✓ T-cell co-stimulating
What the study is looking for
- ✓Inclusion Criteria
- ✓Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L...
- ✓Age \>/= 18 years at the time of signing agreement to take part Form
- ✓activity scale (ECOG) performance status of 0 or 1
- ✓Able to comply with the study protocol, in the investigator's judgment
See the full criteria
Where Is This Study? (2 UK sites)
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Barts Health NHS Trust - St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
How to Get in Touch
Reference Study ID Number: CO40115 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
