Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.

Isabel Blancas, MD

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.

Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)

Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study

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.

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).

Response to treatment with fulvestrant in terms of Overall Survival

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).

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).

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

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).

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

Isabel Blancas

Medical Doctor

All patients have tumors with positive estrogen receptors

One Arm of Metastatic Breast Cancer Patients

Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors

One Arm of Metastatic RE Breast Cancer Patients

Age, Categorical

Age, Continuous

Sex: Female, Male

Spain

Region of Enrollment

ductal

lobulillar

ductal+lobulillar

others

not known

Histologic type

ER positive and PGR positive

ER positive and PGR negative

ER negative and PGR positive

No specifical information

Estrogen receptor and Progesterone receptor status

Dr Isabel Blancas

Progression Free Survival

Clinical Benefit Rate

Overall Survival

Patients wich achieved a clinical benefit with fulvetrant 500: complete response, partial response or stable disease of 24 weeks or longer

Patients With Clinical Benefit

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)

Duration of Clinical Benefit

any toxicity

local pain injection

Muscle-bone pain

Gastrointestinals disorders

Hot flashes

Urinary infection

Weight gain

Vaginitis

Joint pain

Number of Participants With Adverse Events

Group of patients without metastasis in organs like liver or lungs

Patients Without Visceral Metastasis

Group of patients with metastasis in organs like liver or lungs

Patients With Visceral Metastasis

We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.

Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases

Hormonal treatment was tamoxifen or an aromatase inhibitor

Previous Treatment Wiht One Line of Hormonal Treatment

The patients have received at least two hormonal treatment: tamoxifen and aromatase inhibitor

Previous Treatment With Two or More Hormonal Treatment Lines

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.

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

tumor is considered HER2 positive if there is a sobreexpression of the receptor by immunohistochemistry or FISH is positive

Patients With Tumors HER2 Positive

tumor is considered HER2 negative if there is not a sobreexpression of the receptor by immunohistochemistry or FISH is positive

Patients With Tumors HER2 Negative

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.

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

Patients with tumors with high ki67 expression

Patients With Tumors ki67 Positive

Patients with tumors with low ki67 expression

Patients With Tumors ki67 Negative

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.

Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67

All the patients have tumors with positive estrogen receptors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)	NCT01509625	Malignant Neopl...	Fulvestrant	18 Years - 80 Years	Hospital Clinico Universitario San Cecilio
Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)	NCT01509625	Malignant Neopl...	Fulvestrant	18 Years - 80 Years	Hospital Clinico Universitario San Cecilio

Spots Global Cancer Trial Database for malignant neoplasm of breast stage iv