Study identification

PURI

https://redirect.ema.europa.eu/resource/41239

EU PAS number

EUPAS23012

Study ID

41239

Official title and acronym

Observational multicentric national longitudinal study evaluating Ibrance (palbociclib) in a real life setting conditions in patients 70 years old and older presenting a locally advanced or metastatic HR+/HER2- breast cancer (PalomAGE)

DARWIN EU® study

No

Study countries

France

Study description

Breast cancer is the first cause of cancer in women and constitutes the leading cause of cancer death in women. The combination of palbociclib and hormonal therapy profits equally to younger and older women, nonetheless the data in the elderly population remain incomplete, in particular the impact of the knowledge of the geriatric parameters and the fragility of the patients on the safety, feasibility and efficacy of these new treatments. A multicentric prospective observatory study will allow obtaining data in a real life context on the feasibility of IBRANCE (palbociclib) in patients aged 70 years and older and presenting a locally advanced or metastatic HR+/HER2- breast cancer.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Multiple centres: 60 centres are involved in the study

Networks

SoFOG

Contact details

Elisabeth Carola

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable