A Phase II Single Arm Trial Evaluating the Efficacy and Safety of Eribulin in Combination With Bevacizumab for 2-Line Treatment of HER 2-Negative Metastatic Breast Cancer Progressing After 1-Line Therapy With Bevacizumab and Paclitaxel
Unknown Phase 2 NCT02175446
Study Description
In the second-line treatment setting for MBC, many agents, including antitubulin drugs (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated activity, but no agent is clearly superior. Although some combinations of cytotoxic agents provide a small progression-free survival advantage, none has demonstrated an OS advantage, and toxicity is generally greater than for single agents. At present, there is no standard for this treatment setting. New treatments that could delay disease progression without systemic toxicity would represent a significant advancement.
Study Details
- Registry ID:
- NCT02175446
- Conditions:
- Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Phase:
- Phase 2
- Target Enrollment:
- 61 participants
- Start Date:
- Age Range:
- 18–999 years
- Gender:
- Female
- Healthy Volunteers:
- No
Study Locations (17 sites)
-
Università degli Studi di Napoli "Federico II"
Naples, Italy -
A.O.R.N. "A. Cardarelli"
Naples, Italy -
Azienda Ospedaleira Universitaria San Giovanni di Dio e Ruggi d'aragona
Salerno, Italy -
AORN - Ospedali dei Colli Monaldi-Cotugno - C.T.O.
Napoli, Italy -
Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale"
Napoli, Italy -
Ospedale 'F. Spaziani'
Frosinone, Italy -
Ospedale 'SS. Trinità'
Sora, Italy -
Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
Pisa, Italy -
Presidio Ospedaliero Felice Lotti Pontedera
Pontedera, Italy -
Ospedale Unico Versilia
Lido di Camaiore, Italy -
Ospedale San Luca Istituto Tumori Toscano
Lucca, Italy -
Ospedale civile di Macerata
Macerata, Italy -
I.R.C.C.S. Fondazione Salvatore Maugeri
Pavia, Italy -
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, Italy -
Istituto Regina Elena per lo studio e la cura dei tumori
Roma, Italy -
I.R.C.C.S. A.O.U. San Martino - I.S.T.
Genova, Italy -
Azienda Ospedaliera Universitaria Santa Maria della Misericordia di Udine
Udine, Italy
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