Clinical trial NCT02790320: Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer
Official title: Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer: Observational Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Eribulin mesylate
Halaven
Breast cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally recurrent or metastatic advanced breast cancer who were treated with eribulin

Brief summary: The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.

Detailed description: This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.

Eligibility criteria: Inclusion criteria:

1. Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
2. Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
3. Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
4. Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
5. Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.

Exclusion criteria:

1. Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
2. Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.
3. Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):

   1. Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.
   2. Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.

Primary outcomes:
measure: Clinical benefit rate
timeFrame: From signing of informed consent up to 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: From signing of informed consent up to 1 year
measure: Overall survival
timeFrame: From signing of informed consent up to 1 year
measure: Progression-free survival
timeFrame: From signing of informed consent up to 1 year
measure: Change from baseline in tumor markers CA15-3
timeFrame: Baseline and up to 1 year
measure: Time to response from start of treatment
timeFrame: From signing of informed consent up to 1 year
measure: Duration of response
timeFrame: From signing of informed consent up to 1 year
measure: Duration of stabilization
timeFrame: From signing of informed consent up to 1 year
measure: Post-treatment survival
timeFrame: From signing of informed consent up to 1 year
measure: Progression time after interruption
timeFrame: From signing of informed consent up to 1 year
measure: Number of patients with adverse events / serious adverse events
timeFrame: From signing of informed consent up to 1 year
Other outcomes:
Locations:
city: Huesca
country: Spain
facility: Hospital Comarcal de Barbastro
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Clínica Román
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Madrid
country: Spain
facility: Hospital MD Anderson
city: Madrid
country: Spain
facility: Hospital Quirón Madrid
city: Madrid
country: Spain
facility: Hospital Sanitas La Moraleja
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: Navarra
country: Spain
facility: Hospital de Navarra
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Seville
country: Spain
facility: Clínica Esperanza de Triana
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Seville
country: Spain
facility: Hospital Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
References: