Study identification

EU PAS number

EUPAS34260

Study ID

41563

Official title and acronym

Outcome of progression free survival in patients with advanced or metastatic, hormone receptor positive, HER2-negative breast cancer treated with palbociclib in combination with fulvestrant or letrozole

DARWIN EU® study

No

Study countries

Colombia

Study description

An observational, descriptive study with a prospective and retrospective component cohort will be carried out, based on the review of medical records of women with advanced or metastatic, hormonal receptor positive and HER2- negative breast cancer, treated with palbociclib in combination with letrozole or fulvestrant according to the indications approved by National Institute for Drug and Food Vigilance (INVIMA) in Colombia. The index date will be defined as the date of first prescription of palbociclib. Retrospective data extraction will be conducted in 2 phases. In the first phase, data will be extracted on patients that have experienced disease progression, have deceased, have terminated treatment, have been lost to follow up at the time of study initiation (12 months for second line and 30 months for first line). The second phase of data extracted will be on the patients that are on treatment with palbociclib at the time of study initiation and have been followed by their treating physician for the required period of time. More specifically, patients treated with palbociclib in combination with letrozole as first line of treatment will have a maximum collection period of 30 months. For patients with palbociclib in combination with fulvestrant as second line of treatment or greater, they will have a maximum collection period of 12 months. For this study, patient charts will be reviewed in 10 reference HSP located in major cities of Colombia, which will be selected according to their ability to care for cancer patients, approval of the use of palbociclib, and frequency of use of palbociclib. The selected patients should already be under treatment or have been treated with palbociclib in any combination of hormonal therapies. Data collection will take place on 4 time points that correspond to the review of medical records in the 2 phases.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Giovanna Matiz

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer SAS
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable