Locally Advanced orPhase 4NCT02447328

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

A Phase 4 study testing Fulvestrant in people with Locally Advanced or and Metastatic Breast Cancer, run by AstraZeneca at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 130 years, women only
Conditions the study is for: Locally Advanced or, Metastatic Breast Cancer
What is being tested?: Fulvestrant
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 9 sitesSouth Korea
Study dates: 29 May 2015to 16 Sep 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

South Korea9 sites

Research Site
Cheongju-si, 28644
Research Site
Daegu, 41404
Research Site
Goyang-si, 10408
Research Site
Seogu, 49241
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06591
Research Site
Seoul, 135-710

Other trials in South Korea

About this study

Read the 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.

Conditions: Locally Advanced or, Metastatic Breast Cancer
Being tested: Fulvestrant
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FulvestrantDrug
fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.

Study groups in NCT02447328
Study group	Role	What they receive
Single Arm	Experimental	Faslodex treated in the study Receives: Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Percentage of patients with AEs.
Measured: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 201516 Sep 2020

First posted18 May 2015 (estimated)
Study start29 May 2015
Primary completion6 May 2016
Study completion16 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Locally Advanced orStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02447328
Sponsor's protocol ID: D6998L00004
Status last verified: Sep 2021
First submitted: 4 May 2015
Last updated: 5 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02447328
Acronym / sponsor ID: D6998L00004
Conditions: Locally Advanced or, Metastatic Breast Cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 29 May 2015 (actual)
Primary completion: 6 May 2016 (actual)
Study completion: 16 Sep 2020 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 22 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: FulvestrantFaslodex treated in the study

Who may qualify

Ages: 18 to 130 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fulvestrantfulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.	Drug	Single Arm

Primary outcome

Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.
Percentage of patients with AEs.

Results and safety

Results posted to the registry on 22 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	83	82

Primary outcome: Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)

Time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Single Arm n = 81
Adverse Events(AE)	81.5 (71.3 to 89.3)
ADR; based on current South Korea label.	38.3 (27.7 to 49.7)
Serious AE	11.1 (5.2 to 20.1)
Serious ADR	0 (0 to 4.4)
Unexpected AE	71.6 (60.5 to 81.1)
Unexpected ADR	24.7 (15.8 to 35.5)

Population analysed: The safety population: All patients given at least one dose of the study treatment will be included. Data from this population will be used for the safety analysis.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	9 of 81 (11.1%)	66 of 81 (81.5%)	Not reported

Limitations and caveats (from the sponsor): less information in efficacy set.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fulvestrant in people with Locally Advanced or and Metastatic Breast Cancer, run by AstraZeneca at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) (time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02447328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.