Clinical trial NCT02769364: Extended Treatment in Metastatic Breast Cancer With Eribulin
Official title: Long-term Eribulin Treatment in Metastatic Breast Cancer: A Multicenter, Case-study Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Advanced or Metastatic Breast Cancer
Eribulin
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months

Brief summary: Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

Detailed description: This was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. The study was conducted in 26 Spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. An exploratory comparison with a group of short-term responders included in a similar observational study was performed.

Eligibility criteria: Inclusion criteria:

* Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months

Exclusion criteria:

* Lack of accessible clinical records

Primary outcomes:
measure: Overall survival
timeFrame: up to 7 months
measure: Progression free survival (PFS)
timeFrame: up to 7 months
measure: Objective response rate
timeFrame: up to 7 months
measure: Time to response
timeFrame: up to 7 months
measure: Post progression survival
timeFrame: up to 7 months
Secondary outcomes:
measure: Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety
timeFrame: up to 7 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Las Palmas De Gran Canarias
country: Spain
state: Gran Canaria
city: San Sebastián
country: Spain
state: Guipuzcoa
city: Barbastro
country: Spain
state: Huesca
city: Alcorcón
country: Spain
state: Madrid
city: Aravaca
country: Spain
state: Madrid
city: Pozuelo de Alarcón
country: Spain
state: Madrid
city: Pamplona
country: Spain
state: Navarra
city: Bilbao
country: Spain
state: Vizcaya
city: Badajoz
country: Spain
city: Cáceres
country: Spain
city: Jaen
country: Spain
city: Lleida
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Málaga
country: Spain
city: Ourense
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
References: