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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Faslodex treated in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cheongju-si | 28644 | South Korea | |||
| Research Site |
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
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.
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.
Visit 1 (Enrolment visit) Obtained ICF and Eligibility check
Duration of treatment with Fulvestrant (Faslodex®):
Study drug administered biweekly at first cycle. Afterward, Study drug administered monthly. (expected duration of treatment: 6 cycles)
End of Study post dose follow-up visit after study drug discontinuation.
First subject enrolled: 29MAY2015 Last subject last visit: 06MAY2016
This study was conducted from 29 May 2015 to 06 May 2016 and 85 subjects from 9 study centres participated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | fulvestrant (Faslodex®) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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In this study, a total of 85 subjects were enrolled, and 83 of them received study drug open labelled, single arm. The safety population included 81 subjects who met all of the inclusion/exclusion criteria, and 74 of them were included in the efficacy population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | fulvestrant (Faslodex®) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Percentage of patients with AEs. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Adverse events were collected from treatment initiation to end of the study about 6 months for each patient. |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | fulvestrant (Faslodex®) | 9 | 81 | 66 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLANGITIS | Hepatobiliary disorders | MEDRA | Systematic Assessment |
| |
| contusion of brain | Injury, poisoning and procedural complications | MEDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MEDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MEDRA | Systematic Assessment |
| |
| Acute lymphocytic leukaemia (in remission) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA | Systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MEDRA | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment |
| |
| pelvic pain | Reproductive system and breast disorders | MEDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | General disorders | WHO | Systematic Assessment |
| |
| Pain | General disorders | WHO | Systematic Assessment |
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| fatigue | General disorders | WHO | Systematic Assessment |
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| nausea | Gastrointestinal disorders | WHO | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | WHO | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | WHO | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | WHO | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | WHO | Systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | WHO | Systematic Assessment |
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| headache | Nervous system disorders | WHO | Systematic Assessment |
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| dizziness | Nervous system disorders | WHO | Systematic Assessment |
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| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | WHO | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | WHO | Systematic Assessment |
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| pruritus | Skin and subcutaneous tissue disorders | WHO | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | who | Systematic Assessment |
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less information in efficacy set.
14.1 The Institution and the Principal Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Company's prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karin Otter, MD, PhD | AstraZeneca Korea | +82 2 2188 0968 | Karin.Otter@astrazeneca.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Serious ADR |
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| Unexpected AE |
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| Unexpected ADR |
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