Loading
Breast Neoplasms / Breast Cancer / Disitamab vedotin · Phase 1/2 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1/2 trial registration for disitamab vedotin in HER2-expressing advanced breast cancer that has completed enrollment (74 participants) but has not yet reported results in this registry record. No efficacy or safety outcomes are available for evaluation at this time.
Phase 1/2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Breast Cancer, Breast Neoplasms; age from 18 Years. Intervention: Cohort 2: HR+, HER2-low locally advanced or metastatic brea…; Cohort 1: HER2+ locally advanced or metastatic breast cancer; Cohort 3: HR+, HER2 ultra-low or HR-negative, HER2-low loca…. n = 74. 167 sites across 9 countries.
This is a Phase 1/2 trial registration for disitamab vedotin in HER2-expressing advanced breast cancer that has completed enrollment (74 participants) but has not yet reported results in this registry record. No efficacy or safety outcomes are available for evaluation at this time.
This is a registry record with no reported results; no efficacy, safety, or tolerability data are available for clinical decision-making.
The source did not state who this applies to in practice.
This is an active Phase 1/2 trial registration with no results posted; enrollment is complete but outcomes have not been reported in this registry record.
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 (NCT06966453). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 74 participants (ACTUAL). Conditions: Breast Cancer, Breast Neoplasms. Interventions: DRUG: Disitamab vedotin. Primary outcome measures: Objective response (OR) by investigator assessment , From Cycle 1 Day 1 until disease progression by investigator assessment per RECIST version 1.1, or death due to any cause, whichever is earlier; up to approximately 2 years. Brief summary: The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: * have breast cancer that is hard to treat and has spread in the body (advanced cancer) * have tumors that have HER2 on them * have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein). Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks. The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.