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

NCT06338644 | Not Yet Recruiting FDA Drug

• 1 other identifier: HelwanUY
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 bodies

Conditions

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

Keywords

Metastatic breast Cancer, Palbociclib, Pharmacogenomic

Outcome Measures

Primary Outcomes (1)

• 1-year Progression free survival (PFS)

  the time from enrollment until first evidence of disease progression or death

  1 year

Secondary Outcomes (1)

• Neutropenia

  1 year

Study Arms (2)

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

Drug: Palbociclib

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

Drug: Palbociclib

Interventions

Palbociclib DRUG

3 weeks on, 1 week off

Primary resistant to endocrine therapy; Secondary resistant to endocrine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hormone receptor-positive HER2-negative metastatic breast cancer patients

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Related Publications (1)

• 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.

  PMID: 40957562 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at Faculty of Pharmacy

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03