Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500.
Based on the results of the CONFIRM Study, a centralised change in the dosage of Faslodex® to 500 mg/month, with an additional pre-loading dose of 500 mg fourteen days after treatment smart was authorised in Europe; the dose is indicated for the treatment of post-menopausal women with ABC, hormone receptor positive and whose disease had progressed after anti-estrogen therapy.
Several sites worldwide participated in this study, but given the importance of the results obtained and their impact, we believe it is important to have local data available in Spain that would enable us to determine how this new 500 mg dose of Faslodex® behaves in the treatment and to assess treatment response within standard clinical practice and the current indications of this drug.
Therefore, we designed this retrospective, observational study in which we will measure response in term of PFS using data collected from the Clinical History.
Likewise, other variables will be studied: OS, CBR, duration of clinical benefit, tolerability and safety. Patient subgroups, like those who over-express her-2, according to levels of ki-67 and the presence or not of visceral metastases will also be studied.
This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and duration of clinical benefit (DCB, in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500, had occurred at some point between 1 January 2010 and 31 October 2011 (hereinafter, the study period).
Thus, we will obtain the PFS, OS and CBR data, as well as information on safety and tolerability.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate | Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Post-menopausal women with Advanced Breast Cancer (ABC) and estrogen receptor positive (ER+) who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Isabel Blancas, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Cecilio | Granada | Granada | Spain | |||
| Hospital Universitario Virgen de las Nieves |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | One Arm of Metastatic Breast Cancer Patients | All the patients have tumors with positive estrogen receptors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | One Arm of Metastatic RE Breast Cancer Patients | Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | One Arm of Metastatic Breast Cancer Patients | All patients have tumors with positive estrogen receptors |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Isabel Blancas | Hospital Clínico San Cecilio Granada | +34 958023498 | blancaslb@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 22 months |
| Overall Survival | Response to treatment with fulvestrant in terms of Overall Survival | 22 months |
| Duration of Clinical Benefit | Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | 22 months |
| Number of Participants With Adverse Events | 22 months |
| Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | 22 months |
| Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy | To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy | 22 months |
| Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2 | To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | 22 months |
| Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups | 22 months |
| Granada |
| Granada |
| Spain |
| Hospital Torrecardenas Almería | Almería | Spain |
| Complejo Hospitalario de Jaén | Jaén | Spain |
| Hospital SAS Jeréz de la Frontera | Jeréz de La Frontera | Spain |
| Hospital Costa del Sol | Marbella | Spain |
| Hospital Carlos Hayas | Málaga | Spain |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Histologic type | Number | participants |
|
| Estrogen receptor and Progesterone receptor status | Number | participants |
|
|
|
| Secondary | Clinical Benefit Rate | Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | Posted | Number | percentage of patients | 22 months |
|
|
|
| Secondary | Overall Survival | Response to treatment with fulvestrant in terms of Overall Survival | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
|
| Secondary | Duration of Clinical Benefit | Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140) | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
|
| Secondary | Number of Participants With Adverse Events | Posted | Number | 95% Confidence Interval | percentage of patients | 22 months |
|
|
|
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
|
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy | To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups. | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
|
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2 | To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients. | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
|
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients. | Posted | Median | 95% Confidence Interval | month | 22 months |
|
|
|
| 0 |
| 263 |
| 93 |
| 263 |
| Pain in inyection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Musculoskeletal disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hot flushes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urinary infection | Infections and infestations | Systematic Assessment |
|
| Weight gain | Endocrine disorders | Systematic Assessment |
|
| Vaginitis | Infections and infestations | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |