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

NCT02061085 | Completed Phase 2 Results

• 2 other identifiers: OBU-SW-H-022012-004463-41
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 11

Brief Summary

Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma (MBC) previously exposed to taxanes for early stage. The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.

Conditions

Breast Neoplasm; Metastasis

Keywords

Breast Neoplasm Metastasis; Receptor,HER-2; Eribulin; Furans, ketones; Antimitotic agent

Outcome Measures

Primary Outcomes (1)

• Time to Progression

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

  Through study completion, up to 27 months

Secondary Outcomes (3)

• Duration of Response

  Through study completion, up to 27 months

• Clinical Benefit Rate

  Through study completion, up to 27 months

• Progression Free Survival

  Through study completion, up to 27 months

Study Arms (1)

monotherapy treatment with Eribulin

EXPERIMENTAL

Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days

Drug: Eribulin

Interventions

Eribulin DRUG

monotherapy treatment with Eribulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV
• Previous history of early disease (stage I-IIIb), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone
• Patients must have progressed in the 36 months after treatment with taxanes or ixabepilone.
• Age ≥ 18 years
• Given written informed consent
• Index of Eastern Cooperative Oncology Group (ECOG) of 0 or 1
• Patients must have recovered from toxicities related with previous treatment (CTC ≥ 1)
• Measurable or evaluable disease (RECIST 1.1)
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function
• Life expectancy ≥ 3 months

You may not qualify if:

• Breast cancer patients initially diagnosed with local disease advanced or metastatic disease.
• Patients who have previously received cytotoxic therapy Hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment.
• Major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay.
• Brain metastases or leptomeningeal uncontrolled.
• Serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, HIV seropositivity, active bleeding diathesis)
• Other malignancies in the last three years, except: cervical carcinoma in situ, basal cell carcinoma or squamous cell skin carcinoma,that have been properly treated
• Patients who are pregnant or breastfeeding, or adults with reproductive capacity wich are not using effective contraception.
• Patients receiving chronic treatment with systemic corticosteroids or other immunosuppressive drugs (except corticosteroids with a daily dose equivalent to prednisone ≤ 20mg on a stable dose regimen one minimum of 4 weeks prior to study entry. Topical and inhaled corticosteroids are allowed
• Active alcoholism or drugs addiction documented.
• Prior history of noncompliance with medical regimens
• Patients who do not want or can not comply with the study protocol

Sponsors & Collaborators

• MedSIR: lead

Study Sites (11)

Unknown Facility

Zaragoza, Aragon, Spain

Location

Unknown Facility

Palma de Mallorca, Balearic Islands, Spain

Location

Unknown Facility

Las Palmas de Gran Canaria, Canary Islands, Spain

Location

Unknown Facility

Salamanca, Castille and León, Spain

Location

Unknown Facility

Barcelona, Catalonia, Spain

Location

Unknown Facility

Badajoz, Extremadura, Spain

Location

Unknown Facility

A Coruña, Galicia, Spain

Location

Unknown Facility

Pamplona, Navarre, Spain

Location

Unknown Facility

Oviedo, Principality of Asturias, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Valencia, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Ketosis

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Alicia Garcia
• Organization: MedSIR

alicia.garcia@medsir.org

+34 611261467

Study Officials

• Antonio Llombart, MD

  Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: February 12, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Locations

ES (11)