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
1 other identifier
interventional
83
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2015
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedStudy Start
First participant enrolled
May 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2016
CompletedResults Posted
Study results publicly available
March 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2020
CompletedSeptember 5, 2021
September 1, 2021
11 months
May 4, 2015
April 19, 2017
September 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Percentage of patients with AEs.
Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.
Study Arms (1)
Single Arm
EXPERIMENTALFaslodex treated in the study
Interventions
fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (9)
Research Site
Cheongju-si, 28644, South Korea
Research Site
Daegu, 41404, South Korea
Research Site
Goyang-si, 10408, South Korea
Research Site
Seogu, 49241, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
less information in efficacy set.
Results Point of Contact
- Title
- Karin Otter, MD, PhD
- Organization
- AstraZeneca Korea
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2015
First Posted
May 18, 2015
Study Start
May 29, 2015
Primary Completion
May 6, 2016
Study Completion
September 16, 2020
Last Updated
September 5, 2021
Results First Posted
March 22, 2018
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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