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Ibrance / Advanced Or Metastatic Breast Cancer · Observational Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed observational study registration for a real-world database examination of palbociclib safety in advanced or metastatic breast cancer. The registry record reports only study design and eligibility criteria; no outcome results are posted. With only 1 participant actually enrolled, the study is substantially underpowered to support any clinical inference.
Observational. Advanced or Metastatic Breast Cancer; Female; age from 18 Years. Intervention: Ibrance (palbociclib). n = 1. 1 site: United States.
This is a completed observational study registration for a real-world database examination of palbociclib safety in advanced or metastatic breast cancer. The registry record reports only study design and eligibility criteria; no outcome results are posted. With only 1 participant actually enrolled, the study is substantially underpowered to support any clinical inference.
No adverse event rates, risk factor frequencies, or safety data are provided.
This registry record contains no outcome data and cannot inform clinical practice. Readers should await peer-reviewed publication of results, if any, before drawing conclusions.
This is a completed observational registry study with extremely limited enrollment (1 participant) examining real-world safety of palbociclib; results are not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This registry record contains no outcome data and cannot inform clinical practice. Readers should await peer-reviewed publication of results, if any, before drawing conclusions.
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 (NCT06962969). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 1 participants (ACTUAL). Conditions: Advanced or Metastatic Breast Cancer. Interventions: DRUG: Ibrance. Primary outcome measures: Number of participants with adverse events that occur during treatment , From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023; Number of participants with associated risk factors , From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023. Brief summary: The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment. This study will include the data of the following participants: * Adult women (more than18 years of age) with at least one visit with a breast cancer * Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the cancer which is spread from the place where it started to other places in the body. * Patients with a laboratory test positive for hormone receptor and negative for HER2 before or up to 60 days after advanced/metastatic breast cancer diagnosis date. * Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer. This study will look at the safety of palbociclib treatment by looking at the number and severity of the side effects.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.