Trial Outcomes & Findings for Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer (NCT NCT01908101)
NCT ID: NCT01908101
Last Updated: 2020-07-23
Results Overview
Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
From study enrollment until the earliest date of disease progression or death, assessed up to 1 year
Results posted on
2020-07-23
Participant Flow
86 patients signed the study informed consent, but only 68 patients started the Eribulin treatment. Out of those 68 patients only 59 of them were evaluable.
Participant milestones
| Measure |
Treatment (Eribulin Mesylate)
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Treatment (Eribulin Mesylate)
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Incorrect Diagnosis
|
2
|
|
Overall Study
Incorrect Starting Dose
|
1
|
|
Overall Study
Did not complete the first cycle
|
4
|
Baseline Characteristics
Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Eribulin Mesylate)
n=59 Participants
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
|
Age, Continuous
|
52 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From study enrollment until the earliest date of disease progression or death, assessed up to 1 yearPopulation: Patients with metastatic breast cancer (MBC) whose disease has progressed following at least one prior regimen of chemotherapy in the setting of metastatic breast cancer
Kaplan-Meier survival curves will be used to describe PFS, overall and stratified by number of prior metastatic treatment regimens. A 95% confidence interval for the median PFS will be calculated using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Treatment (Eribulin Mesylate)
n=59 Participants
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
PFS
|
3.5 months
Interval 2.6 to 4.6
|
Adverse Events
Treatment (Eribulin Mesylate)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Treatment (Eribulin Mesylate)
n=59 participants at risk
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Sepsis
|
1.7%
1/59 • Number of events 1 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
|
Cardiac disorders
myocardial infarction
|
1.7%
1/59 • Number of events 1 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
Other adverse events
| Measure |
Treatment (Eribulin Mesylate)
n=59 participants at risk
Patients receive eribulin mesylate IV over 2-5 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eribulin Mesylate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
General disorders
Fatigue
|
5.1%
3/59 • Number of events 3 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
5.1%
3/59 • Number of events 3 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
|
Nervous system disorders
Neutropenia
|
22.0%
13/59 • Number of events 13 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
|
Nervous system disorders
Peripheral neuropathy
|
5.1%
3/59 • Number of events 3 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
6.8%
4/59 • Number of events 4 • Adverse events will be collected after the patient has taken the first dose of study drug. After discontinuation from treatment, patients must be followed for all existing AEs for 30 calendar days after the last dose of study drug or until another anti-cancer therapy is initiated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place