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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHelwan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Hormone receptor-positive HER2-negative metastatic breast cancer patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Palbociclib

    Drug

    3 weeks on, 1 week off

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Primary resistant to endocrine therapy1 intervention
Group B: Secondary resistant to endocrine therapy1 intervention

Trial outcomes

Primary outcomes

1

1-year Progression free survival (PFS)

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

Time frame
1 year

Secondary outcomes

1

Neutropenia

Grade 3 or 4 neutropenia

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: