Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer (MADELINE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39939
• EU PAS number:
  EUPAS15951
• Study ID:
  39939
• Official title and acronym:
  Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer (MADELINE)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The primary objectives of this prospective non-interventional study (NIS) are to assess and describe patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic (ABC/mBC) HR+/HER2– breast cancer receiving: 1) IBRANCE in combination with letrozole or fulvestrant as per product label (GROUP 1) or 2) Approved therapies for ABC/mBC other than IBRANCE (GROUP 2)
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Multiple centres: 30 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/03/2016

Actual: 06/03/2016

Study start date

Planned: 23/12/2016

Actual: 02/02/2017

Date of final study report

Planned: 29/09/2020

Actual: 20/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.

Study protocol

Initial protocol

A5481074 Madeline Final Study Protocol_22July2016

Updated protocol

A5481074_PROTOCOL_AMENDMENT 1_20JUN2017_1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable