Trial Outcomes & Findings for E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer (NCT NCT00388726)

NCT ID: NCT00388726

Last Updated: 2020-01-07

Results Overview

Defined as the time from the date of randomization until the date of death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

762 participants

Primary outcome timeframe

From date of randomization until death from any cause

Results posted on

2020-01-07

Participant Flow

This study was recruited at 135 centers in 19 countries during the period of Nov 2006 to May 2009.

Participant milestones

Participant milestones
Measure	Eribulin Mesylate 1.4 mg/kg^2 Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice Treatment of Physician's Choice
Overall Study STARTED	508	254
Overall Study COMPLETED	24	10
Overall Study NOT COMPLETED	484	244

Reasons for withdrawal

Reasons for withdrawal
Measure	Eribulin Mesylate 1.4 mg/kg^2 Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice Treatment of Physician's Choice
Overall Study Adverse Event	50	24
Overall Study Progressive Disease	336	153
Overall Study Clinical Progression	61	36
Overall Study Withdrawal by Subject	10	7
Overall Study Administrative	6	9
Overall Study Physician Decision	18	13
Overall Study Death	3	2

Baseline Characteristics

E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eribulin Mesylate 1.4 mg/kg^2 n=508 Participants Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=254 Participants Treatment of Physician's Choice	Total n=762 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 10.34 • n=5 Participants	55.9 years STANDARD_DEVIATION 10.43 • n=7 Participants	55.2 years STANDARD_DEVIATION 10.37 • n=5 Participants
Sex: Female, Male Female	508 Participants n=5 Participants	254 Participants n=7 Participants	762 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	470 Participants n=5 Participants	233 Participants n=7 Participants	703 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until death from any cause

Population: Intent to Treat

Defined as the time from the date of randomization until the date of death from any cause.

Outcome measures

Outcome measures
Measure	Eribulin Mesylate 1.4 mg/kg^2 n=508 Participants Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=254 Participants Treatment of Physician's Choice
Overall Survival	399 Days Interval 360.0 to 434.0	324 Days Interval 282.0 to 380.0

SECONDARY outcome

Timeframe: Until disease progression or death.

Population: Intent to Treat

Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.

Outcome measures

Outcome measures
Measure	Eribulin Mesylate 1.4 mg/kg^2 n=508 Participants Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=254 Participants Treatment of Physician's Choice
Progression-Free Survival.	113 Days Interval 101.0 to 118.0	68 Days Interval 63.0 to 103.0

SECONDARY outcome

Timeframe: Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.

Population: Response Evaluable Population

Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

Outcome measures

Outcome measures
Measure	Eribulin Mesylate 1.4 mg/kg^2 n=468 Participants Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=214 Participants Treatment of Physician's Choice
Best Overall Response Not Evaluable	2.6 Percent of Participants	1.4 Percent of Participants
Best Overall Response Objective Response Rate (CR+PR)	12.2 Percent of Participants	4.7 Percent of Participants
Best Overall Response Complete Response	0.6 Percent of Participants	0 Percent of Participants
Best Overall Response Partial Response	11.5 Percent of Participants	4.7 Percent of Participants
Best Overall Response Stable Disease	44.4 Percent of Participants	44.9 Percent of Participants
Best Overall Response Progressive Disease	40.6 Percent of Participants	49.1 Percent of Participants
Best Overall Response Unknown	0.2 Percent of Participants	0 Percent of Participants

SECONDARY outcome

Timeframe: From first documented CR or PR until disease progression or death.

Population: Response Evaluable Population

As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Eribulin Mesylate 1.4 mg/kg^2 n=468 Participants Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=214 Participants Treatment of Physician's Choice
Duration of Response.	128 Days Interval 116.0 to 152.0	205 Days Interval 205.0 to 212.0

SECONDARY outcome

Timeframe: From start of study drug administration up to 30 days after the last dose of study drug (approximately up to 42 months)

Population: The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.

Outcome measures

Outcome measures
Measure	Eribulin Mesylate 1.4 mg/kg^2 n=503 Participants Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=247 Participants Treatment of Physician's Choice
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	497 participants	230 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	130 participants	64 participants

Adverse Events

Eribulin Mesylate 1.4 mg/kg^2

Serious events: 130 serious events

Other events: 497 other events

Deaths: 0 deaths

Treatment of Physician's Choice

Serious events: 64 serious events

Other events: 230 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Eribulin Mesylate 1.4 mg/kg^2 n=503 participants at risk Eribulin Mesylate 1.4 mg/kg\^2 on Days 1 and 8	Treatment of Physician's Choice n=247 participants at risk Treatment of Physician's Choice
General disorders Asthenia/Fatigue	54.3% 273/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	40.1% 99/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
General disorders Asthenia	27.4% 138/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	23.9% 59/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
General disorders Fatigue	29.4% 148/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	19.0% 47/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
General disorders Pyrexia	21.3% 107/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	12.6% 31/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
General disorders Mucosal Inflammation	8.7% 44/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	10.1% 25/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
General disorders Peripheral Edema	9.1% 46/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	8.5% 21/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
General disorders Pain	4.8% 24/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	6.5% 16/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Nausea	34.8% 175/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	28.3% 70/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Constipation	24.7% 124/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	20.6% 51/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Diarrhea	19.1% 96/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	18.2% 45/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Vomiting	18.7% 94/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	17.8% 44/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Abdominal Pain Upper	9.1% 46/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	6.1% 15/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Abdominal Pain	7.8% 39/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	8.1% 20/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Dyspepsia	8.3% 42/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	3.2% 8/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Stomatitis	7.6% 38/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	4.9% 12/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Gastrointestinal disorders Dry Mouth	5.8% 29/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	1.2% 3/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Blood and lymphatic system disorders Neutropenia	52.5% 264/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	30.0% 74/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Blood and lymphatic system disorders Anemia	19.3% 97/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	22.7% 56/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Blood and lymphatic system disorders Leukopenia	23.5% 118/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	11.3% 28/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Peripheral Neuropathy	34.6% 174/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	16.2% 40/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Headache	19.5% 98/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	11.7% 29/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Paresthesia	11.1% 56/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	6.5% 16/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Peripheral Sensory Neuropathy	12.3% 62/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	4.0% 10/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Dizziness	7.6% 38/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	5.7% 14/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Neuropathy Peripheral	7.8% 39/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	3.6% 9/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Nervous system disorders Dysgeusia	8.0% 40/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	2.0% 5/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia/Myalgia	22.3% 112/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	11.7% 29/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Back Pain	16.1% 81/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	7.3% 18/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	14.5% 73/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	5.3% 13/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Bone Pain	12.1% 61/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	9.3% 23/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in Extremity	11.5% 58/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	10.1% 25/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	10.7% 54/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	6.9% 17/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	7.4% 37/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	6.1% 15/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	7.6% 38/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	4.5% 11/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle Spasms	7.6% 38/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	4.0% 10/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular Weakness	5.4% 27/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	1.2% 3/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	44.7% 225/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	9.7% 24/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Skin and subcutaneous tissue disorders Rash	6.4% 32/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	6.1% 15/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	1.4% 7/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	13.8% 34/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Infections and infestations Urinary Tract Infection	9.7% 49/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	5.3% 13/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Infections and infestations Upper Respiratory Tract Infection	5.4% 27/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	2.0% 5/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.7% 79/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	12.6% 31/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.7% 74/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	8.5% 21/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	7.2% 36/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	1.2% 3/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 12/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	5.3% 13/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Investigations Weight Decreased	21.3% 107/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	14.6% 36/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Investigations Alanine Aminotransferase Increased	5.4% 27/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	2.4% 6/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Metabolism and nutrition disorders Anorexia	20.1% 101/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	13.0% 32/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Metabolism and nutrition disorders Hypokalemia	7.2% 36/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	2.0% 5/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Psychiatric disorders Insomnia	7.6% 38/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	4.0% 10/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Psychiatric disorders Anxiety	5.4% 27/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	4.5% 11/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Psychiatric disorders Depression	5.4% 27/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	1.2% 3/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.
Eye disorders Lacrimation Decreased	7.0% 35/503 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.	3.2% 8/247 The safety analysis set was all participants who were randomized and who received at least a partial dose of study treatment.