Malignant Neoplasm of Breast Stage IV
Conditions
Keywords
Fulvestrant, Faslodex
Brief summary
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.
Detailed description
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.
Interventions
DRUGFulvestrant
It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.
Sponsors
Isabel Blancas
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent from patients when possible. * In the event of patients who are deceased at the time of inclusion, no signed informed consent will be available; thus, the investigator assumes the responsibility of data protection and confidentiality and of safeguarding the processing of the data. * Post-menopausal women. * Diagnosed with locally advanced or Metastatic Breast Cancer with histological/cytological confirmation. * Documented estrogen receptor positive status for the primary tumour. * Patient who, after progression with a previous anti-estrogen treatment, received treatment at some time with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose during the study period.
Exclusion criteria
* Having received treatment with unapproved or experimental drugs during the study period. * Presenting another concomitant cancer other than stage I cervical cancer or cutaneous tumours without lymph node or distant involvement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 22 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 22 months | Response to treatment with fulvestrant in terms of Overall Survival |
| Duration of Clinical Benefit | 22 months | 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). |
| Number of Participants With Adverse Events | 22 months | — |
| Clinical Benefit Rate | 22 months | 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 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 | 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 |
| 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 | 22 months | 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). |
| Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | 22 months | 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 |
| Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | 22 months | 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). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 272 |
| Total | 272 |
Baseline characteristics
| Characteristic | One Arm of Metastatic RE Breast Cancer Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 138 Participants |
| Age, Categorical Between 18 and 65 years | 134 Participants |
| Age, Continuous age | 65 years |
| Estrogen receptor and Progesterone receptor status ER negative and PGR positive | 1 participants |
| Estrogen receptor and Progesterone receptor status ER positive and PGR negative | 61 participants |
| Estrogen receptor and Progesterone receptor status ER positive and PGR positive | 197 participants |
| Estrogen receptor and Progesterone receptor status No specifical information | 13 participants |
| Histologic type ductal | 208 participants |
| Histologic type ductal+lobulillar | 7 participants |
| Histologic type lobulillar | 37 participants |
| Histologic type not known | 13 participants |
| Histologic type others | 7 participants |
| Region of Enrollment Spain | 272 participants |
| Sex: Female, Male Female | 272 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 93 / 263 |
| serious Total, serious adverse events | 0 / 263 |
Outcome results
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.
Time frame: 22 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Progression Free Survival | 10.6 month |
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).
Time frame: 22 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Clinical Benefit Rate | 56.5 percentage of patients |
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).
Time frame: 22 months
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Duration of Clinical Benefit | 18.4 month |
Secondary
Number of Participants With Adverse Events
Time frame: 22 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | any toxicity | 35.4 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | local pain injection | 9.9 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Muscle-bone pain | 7.2 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Gastrointestinals disorders | 6.8 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Hot flashes | 6.1 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Urinary infection | 0.8 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Weight gain | 0.8 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Vaginitis | 0.4 percentage of patients |
| One Arm of Metastatic Breast Cancer Patients | Number of Participants With Adverse Events | Joint pain | 16 percentage of patients |
Secondary
Overall Survival
Response to treatment with fulvestrant in terms of Overall Survival
Time frame: 22 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Overall Survival | 43.2 month |
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
Time frame: 22 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | 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 | 11.2 month |
| Patients With Visceral Metastasis | 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 | 9.2 month |
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
Time frame: 22 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | 9.6 month |
| Patients With Visceral Metastasis | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | 10.0 month |
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).
Time frame: 22 months
Population: We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer Patients | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | 10.6 month |
| Patients With Visceral Metastasis | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | 10 month |
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).
Time frame: 22 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Arm of Metastatic Breast Cancer 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 | 10.2 month |
| Patients With Visceral Metastasis | 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 | 10.3 month |