Status:
COMPLETED
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
Lead Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Breast
Neoplasm Malignant
Eligibility:
FEMALE
18+ years
Brief Summary
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); ...
Detailed Description
This is an open-label, longitudinal, prospective, multicentre cohort study. Eligible patients are pre- and postmenopausal women with a histologically proven HR+ MBC, candidate to receive palbociclib p...
Eligibility Criteria
Inclusion
- Pre- and postmenopausal women with a histologically proven HR+MBC, candidate to receive palbociclib plus ET as first or subsequent line of therapy according to their contingent clinical situation.
- HER2- disease (IHC 0-1 or IHC 2, confirmed as FISH negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months.
- Adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration
Exclusion
- ER- PgR- disease
- HER2+ disease (IHC 3 or IHC 2, confirmed as FISH positive)
- Any cardiovascular, renal or hepatic condition that would compromise conditions in the opinion of the investigator
Key Trial Info
Start Date :
December 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT04524728
Start Date
December 1 2016
End Date
June 1 2020
Last Update
August 24 2020
Active Locations (1)
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1
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy, 27100