Loading
SGN-LIV1A / Metastatic Breast Cancer / Atezolizumab · Phase 1/2 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1/2 umbrella trial evaluating multiple drug combinations across seven disease cohorts in metastatic or locally advanced breast cancer. No efficacy or safety results are available in this registry record; the study is currently recruiting. Clinical utility cannot be assessed until results are published.
Phase 1/2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Metastatic Breast Cancer; age from 18 Years. Intervention: Atezolizumab + Nab-Paclitaxel + Tocilizumab; Atezolizumab + Sacituzumab Govitecan; Atezolizumab + Ipatasertib; Atezolizumab + SGN-LIV1A; Atezolizumab + Selicrelumab + Bevacizumab; Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin…. Compared with: Atezolizumab + Nab-Paclitaxel — Active Comparator; Capecitabine — Active Comparator. n = 1,132. 53 sites across 9 countries.
This is a planned Phase 1/2 umbrella trial evaluating multiple drug combinations across seven disease cohorts in metastatic or locally advanced breast cancer. No efficacy or safety results are available in this registry record; the study is currently recruiting. Clinical utility cannot be assessed until results are published.
Efficacy and safety data unavailable until study completion and publication.
The source did not state who this applies to in practice.
This is a clinical trial registry record for a Phase 1/2 umbrella study with no results posted; it describes planned enrollment and study design only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03424005). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 1132 participants (ESTIMATED). Conditions: Metastatic Breast Cancer. Interventions: DRUG: Capecitabine; DRUG: Atezolizumab; DRUG: Ipatasertib; DRUG: SGN-LIV1A; DRUG: Bevacizumab; DRUG: Chemotherapy (Gemcitabine + Carboplatin or Eribulin); DRUG: Selicrelumab; DRUG: Tocilizumab; DRUG: Nab-Paclitaxel; DRUG: Sacituzumab Govitecan; DRUG: Abemaciclib; DRUG: Fulvestrant; DRUG: Ribociclib (Dose #1); DRUG: Inavolisib (Dose #1); DRUG: Trastuzumab Deruxtecan; DRUG: Ribociclib (Dose #2); DRUG: Letrozole; DRUG: Inavolisib (Dose #2); DRUG: Empagliflozin; DRUG: Palbociclib; DRUG: Metformin; DRUG: Atirmociclib; DRUG: Giredestrant. Primary outcome measures: Objective Response Rate (ORR) , Baseline until disease progression or loss of clinical benefit (up to approximately 12 years). Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.