Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer
This study has been completed.
Sponsor:
Hellenic Oncology Research Group
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fulvestrant
U.S. FDA Resources
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
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 May 16, 2013