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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Palbociclib
Drug3 weeks on, 1 week off
Treatment groups
Trial outcomes
Primary outcomes
1-year Progression free survival (PFS)
the time from enrollment until first evidence of disease progression or death
Secondary outcomes
Neutropenia
Grade 3 or 4 neutropenia
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: