Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01399086
First received: May 23, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Drug: Fulvestrant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study of Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer in Greece (The 'RESPONSE' Study)

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: > 6 months ] [ Designated as safety issue: No ]
    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

  • Tumor growth control [ Time Frame: >6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 140
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fulvestrant Drug: Fulvestrant
250mg on d1,15,29 or 250mg on d1 q28days
Other Name: Faslodex

Detailed 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?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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 that fulfil the following-mentioned eligibility criteria and have initiated therapy with fuvestrant 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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399086

Locations
Greece
"Ag.Georgios" General Hospital of Chania
Chania, Crete, Greece
University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
IASO General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
"Agios Savvas" Anticancer Hospital of Athens
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01399086     History of Changes
Other Study ID Numbers: CT/10.10
Study First Received: May 23, 2011
Last Updated: March 12, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Cancer
Breast
Metastatic
Hormonotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on July 29, 2014