Studies low white blood cell counts from palbociclib in breast cancer
Observes low white blood cell counts in people with advanced breast cancer taking palbociclib.
Key facts
- Who runs it
- Assiut University
- Where
- Al Madīnah, Saudi ArabiaSee the site
- Trial code
- Registry title
- Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
- Status
- Not yet recruiting
- People taking part
- 54 people, planned
- Started
- Nov 2023
- Expected to end
- Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Palbociclib
- Record updated
- 11 October 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with metastatic breast cancer that is hormone receptor-positive and HER2 negative, who start Palbociclib with hormonal treatment as their first treatment for metastatic disease.
- Sex
- All sexes can join.
- Disease stage
- Metastatic breast cancer, either metastatic at first diagnosis (de novo) or recurrent. Hormone receptor-positive and HER2 negative, confirmed by tissue examination.
- Earlier treatment
- People cannot have had any earlier systemic therapy for metastatic disease.
- Biomarker or test result
- Hormone receptor-positive and HER2 negative.
Main reasons for not taking part
- People with co-morbidity
- Pregnant women
- Breastfeeding women
- ECOG performance status above 2
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Histological pathological confirmation of primary breast cancer or metastatic disease
- Hormonal receptor-positive, HER2 negative
- Metastatic breast cancer at presentation (Den novo) or recurrent
- Patients did not receive any previous systemic therapy for metastatic disease
- Performance status (ECOG) 0-2
Who cannot take part
- Patient with co-morbidity
- Pregnant and breast lactating women
Where in Saudi Arabia
- Asmaa Imam AhmedAl Madīnah, Saudi ArabiaContact: Asmaa I AhmedNo longer taking part
About the trial
What the trial wants to find out
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.
The 2 groups in the trial
- 1
cases developed neutropenia Grade 0-2 with palbociclib administration
Treatment: Palbociclib
- 2
cases developed neutropenia Grade 3-4 with palbociclib administration
Treatment: Palbociclib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
- Plain-language title
- Studies low white blood cell counts from palbociclib in breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 October 2023