Locally Advanced or, Metastatic Breast Cancer
Conditions
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.
Interventions
DRUGFulvestrant
fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Adverse events were collected from treatment initiation to end of the study about 6 months for each patient. | Percentage of patients with AEs. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
1. Visit 1 (Enrolment visit) Obtained ICF and Eligibility check 2. Duration of treatment with Fulvestrant (Faslodex®): Study drug administered biweekly at first cycle. Afterward, Study drug administered monthly. (expected duration of treatment: 6 cycles) 3. End of Study post dose follow-up visit after study drug discontinuation.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm fulvestrant (Faslodex®) | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous Age | 56.6 years STANDARD_DEVIATION 9.34 |
| Sex: Female, Male Female | 81 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 | 66 / 81 |
| serious Total, serious adverse events | 9 / 81 |
Outcome results
Primary
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
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.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Adverse Events(AE) | 81.5 Percentage of participants |
| Single Arm | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | ADR; based on current South Korea label. | 38.3 Percentage of participants |
| Single Arm | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Serious AE | 11.1 Percentage of participants |
| Single Arm | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Serious ADR | 0 Percentage of participants |
| Single Arm | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Unexpected AE | 71.6 Percentage of participants |
| Single Arm | Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) | Unexpected ADR | 24.7 Percentage of participants |