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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Unnamed facility
Zaragoza, Aragon, Spain
Unnamed facility
Palma de Mallorca, Balearic Islands, Spain
Unnamed facility
Las Palmas de Gran Canaria, Canary Islands, Spain
Unnamed facility
Salamanca, Castille and León, Spain
Time to Progression
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Time frame: Through study completion, up to 27 months
Duration of Response
Duration of response
Time frame: Through study completion, up to 27 months
Clinical Benefit Rate
Time frame: Through study completion, up to 27 months
Progression Free Survival
Time frame: Through study completion, up to 27 months
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Unnamed facility
Barcelona, Catalonia, Spain
Unnamed facility
Badajoz, Extremadura, Spain
Unnamed facility
A Coruña, Galicia, Spain
Unnamed facility
Pamplona, Navarre, Spain
Unnamed facility
Oviedo, Principality of Asturias, Spain
Unnamed facility
Madrid, Spain
...and 1 more locations