Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients. (Palbociclib)
March 24, 2024 updated by: Yassmin Genina, Helwan University
Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC.
Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc.
Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety
Study Type
Observational
Enrollment (Estimated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Hormone receptor-positive HER2-negative metastatic breast cancer patients
Description
Inclusion Criteria:
1. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.
4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.
Exclusion Criteria:
- Prior exposure to fulvestrant or everolimus.
- Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
- Patients refusing to sign the written informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Primary resistant to endocrine therapy
Primary endocrine resistance is defined as a relapse within 2 years of adjuvant endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy for advanced or MBC
|
3 weeks on, 1 week off
|
|
Secondary resistant to endocrine therapy
Secondary resistance is defined in early BC as a relapse that occurs after at least 2 years of endocrine therapy and during or within the first year of completing adjuvant endocrine therapy.
In advanced BC or MBC, secondary resistance is defined as disease progression after more than 6 months of endocrine therapy
|
3 weeks on, 1 week off
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1-year Progression free survival (PFS)
Time Frame: 1 year
|
the time from enrollment until first evidence of disease progression or death
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neutropenia
Time Frame: 1 year
|
Grade 3 or 4 neutropenia
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
March 24, 2024
First Submitted That Met QC Criteria
March 24, 2024
First Posted (Actual)
March 29, 2024
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 24, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HelwanUY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.