Clinical trial NCT02061085: Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment
Official title: A Phase IIa Prospective, Multicenter, Open and Not Controlled of the Efficacy and Tolerability on the First Line Treatment With Eribulin as a Unic Agent on Patients With HER2 Negative Metastatic Breast Cancer Previously Treated With Taxanes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasm
Metastasis
Keywords: Breast Neoplasm Metastasis
Receptor,HER-2
Eribulin
Furans, ketones
Antimitotic agent
Lead sponsor: MedSIR
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to Progression
timeFrame: Through study completion, up to 27 months
Secondary outcomes:
measure: Duration of Response
timeFrame: Through study completion, up to 27 months
measure: Clinical Benefit Rate
timeFrame: Through study completion, up to 27 months
measure: Progression Free Survival
timeFrame: Through study completion, up to 27 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
state: Aragón
city: Oviedo
country: Spain
state: Asturias
city: Salamanca
country: Spain
state: Castilla Y León
city: Barcelona
country: Spain
state: Cataluña
city: Badajoz
country: Spain
state: Extremadura
city: La Coruña
country: Spain
state: Galicia
city: Palma de Mallorca
country: Spain
state: Illes Balears
city: Las Palmas De Gran Canaria
country: Spain
state: Islas Canarias
city: Pamplona
country: Spain
state: Navarra
city: Madrid
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Valencia
name: Antonio Llombart, MD
role: PRINCIPAL_INVESTIGATOR
References: