Trial Outcomes & Findings for 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 (NCT NCT02447328)
NCT ID: NCT02447328
Last Updated: 2021-09-05
Results Overview
Percentage of patients with AEs.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.
Results posted on
2021-09-05
Participant Flow
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.
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.
Participant milestones
| Measure |
Single Arm
fulvestrant (Faslodex®)
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single Arm
fulvestrant (Faslodex®)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Single Arm
n=81 Participants
fulvestrant (Faslodex®)
|
|---|---|
|
Age, Continuous
Age
|
56.6 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Percentage of patients with AEs.
Outcome measures
| Measure |
Single Arm
n=81 Participants
fulvestrant (Faslodex®)
|
|---|---|
|
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Adverse Events(AE)
|
81.5 Percentage of participants
Interval 71.3 to 89.3
|
|
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
ADR; based on current South Korea label.
|
38.3 Percentage of participants
Interval 27.7 to 49.7
|
|
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Serious AE
|
11.1 Percentage of participants
Interval 5.2 to 20.1
|
|
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Serious ADR
|
0 Percentage of participants
Interval 0.0 to 4.4
|
|
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Unexpected AE
|
71.6 Percentage of participants
Interval 60.5 to 81.1
|
|
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
Unexpected ADR
|
24.7 Percentage of participants
Interval 15.8 to 35.5
|
Adverse Events
Single Arm
Serious events: 9 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=81 participants at risk
fulvestrant (Faslodex®)
|
|---|---|
|
Hepatobiliary disorders
CHOLANGITIS
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
contusion of brain
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Hydronephrosis
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Investigations
Blood creatinine increased
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia (in remission)
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
1.2%
1/81 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
pelvic pain
|
1.2%
1/81 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Single Arm
n=81 participants at risk
fulvestrant (Faslodex®)
|
|---|---|
|
General disorders
back pain
|
11.1%
9/81 • Number of events 11 • 6 months
|
|
General disorders
Pain
|
7.4%
6/81 • Number of events 6 • 6 months
|
|
General disorders
fatigue
|
6.2%
5/81 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
nausea
|
12.3%
10/81 • Number of events 12 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
8.6%
7/81 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
7.4%
6/81 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
5/81 • Number of events 5 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.3%
10/81 • Number of events 12 • 6 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
7.4%
6/81 • Number of events 6 • 6 months
|
|
Nervous system disorders
headache
|
8.6%
7/81 • Number of events 7 • 6 months
|
|
Nervous system disorders
dizziness
|
11.1%
9/81 • Number of events 10 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
7.4%
6/81 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
5/81 • Number of events 5 • 6 months
|
|
Skin and subcutaneous tissue disorders
pruritus
|
6.2%
5/81 • Number of events 5 • 6 months
|
|
Skin and subcutaneous tissue disorders
rash
|
6.2%
5/81 • Number of events 5 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER