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A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)


To date, there are no available data on the use of fulvestrant in the treatment of
postmenopausal women with metastatic breast cancer in current clinical practice in Greece.
In view of this significant lack of knowledge, we designed this retrospective study in order
to evaluate the effectiveness of fulvestrant in real-life settings, by obtaining data
regarding the use of fulvestrant in current clinical practice among treating physicians in
Greece. This retrospective study aims to address the following questions:

- What is the clinical outcome of fulvestrant treatment in terms of TTP when used in
metastatic breast cancer in a real life clinical setting?

- What is the positioning of fulvestrant in the hormone therapy sequencing in metastatic
breast cancer in Greece?

- What are the other clinical outcomes (ORR, duration of response, CBR) of fulvestrant
treatment in metastatic breast cancer in a real life clinical setting and what is the
relation between clinical outcomes and fulvestrant's position in the treatment
sequence?

- What is the usual duration of fulvestrant treatment in metastatic breast cancer in the
real life clinical setting and which are the reasons for treatment discontinuation?

- Treatment failure with fulvestrant: what is the next step in sequencing according to
patients' breast cancer treatment history?


Inclusion Criteria:



- Postmenopausal women with ER-positive and/or PgR-positive breast cancer who have
failed at least one prior endocrine therapy, either as adjuvant treatment or for the
treatment of advanced disease

- Patients who have received treatment with fulvestrant for metastatic breast cancer
and have completed/discontinued the treatment regardless of outcome/reason for
discontinuation (except for treatment discontinuation for non-clinical reasons)

- Patients who were at postmenopausal status at the time of treatment with fulvestrant

Exclusion Criteria:

- Patients who are currently undergoing treatment with fulvestrant

- Investigators/treating physicians with no available electronical or paper-based
medical records

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Time to Progression

Outcome Description:

To evaluate the time to progression (TTP) from the initiation of fulvestrant treatment in postmenopausal women with endocrine-positive breast cancer who have failed at least one prior endocrine therapy, either as adjuvant treatment or for the treatment of advanced disease

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Vassilis Georgoulias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/10.10

NCT ID:

NCT01399086

Start Date:

April 2011

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Cancer
  • Breast
  • Metastatic
  • Hormonotherapy
  • Breast Neoplasms

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