Trial Outcomes & Findings for Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment (NCT NCT02061085)

NCT ID: NCT02061085

Last Updated: 2025-06-08

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: Through study completion, up to 27 months
• Results posted on: 2025-06-08

Participant Flow

A total of 53 taxane-resistant patients with HER2- locally advanced or MBC treated with Eribulin as first-line chemotherapy were enrolled between 2013 and 2015 in a total of 14 sites.

Patients must comply: MBC HER2- stage IIIb/IV. Previous early disease (I-IIIb) diagnosis, surgically resected and treated with chemotherapy 12w (must include taxane or ixabepilone). Must have progressed 48m after. Age ≥ 18 years. ECOG performance status 0 or 1. Measurable or evaluable disease (RECIST 1.1). Adequate bone marrow, hepatic and renal function. Life expectancy ≥ 3m.

Participant milestones

Measure	Monotherapy Treatment With Eribulin Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Overall Study STARTED	53
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Monotherapy Treatment With Eribulin Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Overall Study Adverse Event	8

Baseline Characteristics

Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment

Baseline characteristics by cohort

Measure	Monotherapy Treatment With Eribulin n=53 Participants Eribulin Dosage: 1.4 mg/m2. Route of administration: IV bolus. Schedule of cycle: D1 and D8 every 21 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Spain	49 participants n=5 Participants
Region of Enrollment Portugal	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, up to 27 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)

Outcome measures

Measure	Monotherapy Treatment With Eribulin n=53 Participants Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Time to Progression	4.1 months Interval 3.2 to 6.6

SECONDARY outcome

Timeframe: Through study completion, up to 27 months

Duration of response

Outcome measures

Measure	Monotherapy Treatment With Eribulin n=53 Participants Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Duration of Response	4.5 months Interval 2.1 to 20.9

SECONDARY outcome

Timeframe: Through study completion, up to 27 months

Outcome measures

Measure	Monotherapy Treatment With Eribulin n=53 Participants Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Clinical Benefit Rate	14 Participants

SECONDARY outcome

Timeframe: Through study completion, up to 27 months

Outcome measures

Measure	Monotherapy Treatment With Eribulin n=53 Participants Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Progression Free Survival	4.1 Months Interval 3.2 to 6.6

Adverse Events

Monotherapy Treatment With Eribulin

Serious events: 11 serious events

Other events: 39 other events

Deaths: 22 deaths

Serious adverse events

Measure	Monotherapy Treatment With Eribulin n=53 participants at risk Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Vascular disorders Pleural effusion	1.9% 1/53 • Number of events 3 • Through study completion, up to 27 months
Vascular disorders Pulmonar embolism	1.9% 1/53 • Number of events 3 • Through study completion, up to 27 months
Vascular disorders Cerebrovascular accident	1.9% 1/53 • Number of events 3 • Through study completion, up to 27 months
Vascular disorders Pulmonary tromboembolism	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
General disorders Cephalea	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
General disorders Anxiety	1.9% 1/53 • Number of events 1 • Through study completion, up to 27 months
Gastrointestinal disorders Parcial hepatoctomy	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
Gastrointestinal disorders Nausea	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
Gastrointestinal disorders Vomiting	3.8% 2/53 • Number of events 5 • Through study completion, up to 27 months
Respiratory, thoracic and mediastinal disorders Mucositis management	1.9% 1/53 • Number of events 3 • Through study completion, up to 27 months
Renal and urinary disorders Pyelonephritis right	1.9% 1/53 • Number of events 1 • Through study completion, up to 27 months
Renal and urinary disorders Pyelonephritis acute	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
Musculoskeletal and connective tissue disorders Fracture	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
Infections and infestations Klebsiella test positive	1.9% 1/53 • Number of events 2 • Through study completion, up to 27 months
Skin and subcutaneous tissue disorders Subcutaneous infection	1.9% 1/53 • Number of events 6 • Through study completion, up to 27 months

Other adverse events

Measure	Monotherapy Treatment With Eribulin n=53 participants at risk Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Nervous system disorders Neuropathy peripheral	18.9% 10/53 • Number of events 10 • Through study completion, up to 27 months
General disorders Dry mouth	7.5% 4/53 • Number of events 4 • Through study completion, up to 27 months
Gastrointestinal disorders Nausea	26.4% 14/53 • Number of events 14 • Through study completion, up to 27 months
Gastrointestinal disorders Constipation	18.9% 10/53 • Number of events 10 • Through study completion, up to 27 months
Gastrointestinal disorders Anorexia and bulimia syndrome	18.9% 10/53 • Number of events 10 • Through study completion, up to 27 months
Gastrointestinal disorders Abdominal pain	13.2% 7/53 • Number of events 7 • Through study completion, up to 27 months
Skin and subcutaneous tissue disorders Alopecia	34.0% 18/53 • Number of events 18 • Through study completion, up to 27 months
Musculoskeletal and connective tissue disorders Asthenia	13.2% 7/53 • Number of events 7 • Through study completion, up to 27 months
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	13.2% 7/53 • Number of events 7 • Through study completion, up to 27 months
Musculoskeletal and connective tissue disorders Bone pain	9.4% 5/53 • Number of events 5 • Through study completion, up to 27 months
Musculoskeletal and connective tissue disorders Myalgia	9.4% 5/53 • Number of events 5 • Through study completion, up to 27 months
Metabolism and nutrition disorders Alanine aminotransferase increased	1.9% 1/53 • Number of events 1 • Through study completion, up to 27 months

Additional Information

Alicia Garcia

MedSIR

Phone: +34 611261467

Email: alicia.garcia@medsir.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place