A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Primary Purpose
Locally Advanced or, Metastatic Breast Cancer
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fulvestrant
Sponsored by
About this trial
This is an interventional other trial for Locally Advanced or
Eligibility Criteria
Inclusion Criteria:
- Post menopausal status women
- Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
- Estrogen receptor positive
- Radiographic progression of disease after the prior therapy
- Patients who agree to participate in this study and sign the informed consent
Exclusion Criteria:
- Patients who are treated with fulvestrant
- Patients who are being treated with the other antitumor agents
- Pregnancy or lactating women
- History of hypersensitivity to any of included ingredients (eg. Castor oil)
- Patients who are considered not fit for the study by investigators
- Patients who have severe dysfunction of liver or kidney
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Faslodex treated in the study
Outcomes
Primary Outcome Measures
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Percentage of patients with AEs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02447328
Brief Title
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Official Title
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2015 (Actual)
Primary Completion Date
May 6, 2016 (Actual)
Study Completion Date
September 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months
Detailed Description
This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®) as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast cancer.
All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study will be performed for about 3 years and approximately 100 patients(actual target will be 80 treated patients) will be enrolled in about 10 investigational sites.
After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.
Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. The information of adverse events will be collected after the 1st dose of IP injection. In case that the evaluation of tumor response might be performed in regular clinical practice, those data will also be collected as well. The quality of life will also be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or, Metastatic Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Faslodex treated in the study
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.
Primary Outcome Measure Information:
Title
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Description
Percentage of patients with AEs.
Time Frame
Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post menopausal status women
Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
Estrogen receptor positive
Radiographic progression of disease after the prior therapy
Patients who agree to participate in this study and sign the informed consent
Exclusion Criteria:
Patients who are treated with fulvestrant
Patients who are being treated with the other antitumor agents
Pregnancy or lactating women
History of hypersensitivity to any of included ingredients (eg. Castor oil)
Patients who are considered not fit for the study by investigators
Patients who have severe dysfunction of liver or kidney
Facility Information:
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Research Site
City
Seo-Gu
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
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