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Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

NCT ID: NCT06338644

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-09-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Hormone-receptor-positive Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Metastatic Breast Cancer

Keywords

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Metastatic breast Cancer, Palbociclib, Pharmacogenomic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Palbociclib

Intervention Type DRUG

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

Palbociclib

Intervention Type DRUG

3 weeks on, 1 week off

Interventions

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Palbociclib

3 weeks on, 1 week off

Intervention Type DRUG

Eligibility Criteria

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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

1. Prior exposure to fulvestrant or everolimus.
2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
3. Patients refusing to sign the written informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Yassmin Genina

Assistant lecturer at Faculty of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Mohamed Ebid AI, Fahim Genina YM, Shawky Haffez HR, Ahmed Hakam SH, Hassan Kassem LM, Mohamed AbdelMotaleb SM. Palbociclib in endocrine-resistant metastatic breast cancer: real-world outcomes. Expert Rev Anticancer Ther. 2025 Sep 21:1-10. doi: 10.1080/14737140.2025.2560941. Online ahead of print.

Reference Type DERIVED
PMID: 40957562 (View on PubMed)

Other Identifiers

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HelwanUY

Identifier Type: -

Identifier Source: org_study_id