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

Not yet recruiting

• Conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Metastatic Breast Cancer; Hormone-receptor-positive Breast Cancer
• Interventions: Drug: Palbociclib

• Registration Number: NCT06338644
• Lead Sponsor: Helwan University

Brief Summary

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 bo...

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, whethe...

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Study Start: 2024-07-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

  2. 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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary resistant to endocrine therapy	Palbociclib	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
Secondary resistant to endocrine therapy	Palbociclib	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

Primary Outcome Measures

Name	Time	Method
1-year Progression free survival (PFS)	1 year	the time from enrollment until first evidence of disease progression or death

Secondary Outcome Measures

Name	Time	Method
Neutropenia	1 year	Grade 3 or 4 neutropenia