Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399086
• Other study ID #: CT/10.10
• Status: Completed
• Phase: N/A
• First received: May 23, 2011
• Last updated: March 12, 2012
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: March 2012
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

This is a retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on patients who have commenced treatment with fulvestrant after January 1st of 2007. All necessary information for the purposes of the present study will be collected with the use of a paper-Case Record Form.

Description:

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant
250mg on d1,15,29 or 250mg on d1 q28days

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"Agios Savvas" Anticancer Hospital of Athens	Athens
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	IASO General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	"Ag.Georgios" General Hospital of Chania	Chania	Crete
Greece	University Hospital of Crete, Dep of Medical Oncology	Heraklion	Crete
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa
Greece	Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression	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	1 year	No
Secondary	Objective Response Rate	To evaluate the objective response rate (ORR), i.e. the rate of both complete and partial response, and to estimate the duration of response while on treatment with fulvestrant	> 6 months	No
Secondary	Tumor growth control	To evaluate the clinical benefit rate (CBR), i.e. the rate of both complete and partial response as well as stable disease = 6 months, while on treatment with fulvestrant, where applicable	>6 months	No