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An International, Phase 3, Multicenter, Randomized, Open-LabTrial Comparing Balixafortide in combination with Eribulin versus Eribulin alone in Patients with HER2 negative, Locally Recurrent or Metastatic Breast Cancer POL6326-009 - FORTRESS

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Patients at least 18 years of age (or according to local regulation).
- Histologically confirmed Breast cancer
- Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer
- Refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy
- At least 14 days from the completion of any previous cancer therapy
- Adequate organ function
- Life expectancy of 3 months or more
- Willing and able to comply with the protocol and able to understand and willing to sign an informed consent

Criteri di esclusione: 

- Previously treated with eribulin
- Peripheral neuropathy Grade ≥3
- Receipt of prior CXCR4 therapy
- Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study
- Breast feeding or pregnant
- Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes

Trattamento sperimentale: 

Balixafortide

Trattamento di controllo: 

Eribulina

Obiettivi primari dello studio: 

To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on (i) PFS in the Overall Population and (ii) PFS and ORR in the 3rd line + population.

Obiettivi secondari dello studio: 

- To compare the OS between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm.
- To compare measures of tumor response between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm.
- To evaluate the safety and tolerability of balixafortide + eribulin versus eribulin monotherapy.

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Riferimento: Prof. Giampaolo Bianchini
Telefono: 0226436523
Email: bianchini.giampaolo@hsr.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Prof.ssa Marina Cazzaniga
Telefono: 0392333539
Email: dir.centroricerca@asst-monza.it

 

Sud Italia e isole

AOU Policlinico Vittorio Emanuele PO G. Rodolico
Via S. Sofia 78 - 95123 Catania - CT

 

Azienda Ospedaliera Universitaria Federico II
Via Sergio Pansini 5 - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-004211-42

Data di inserimento: 17.12.2019

Promotore

Polyphor Ltd.

CRO

PPD

Principal Investigator ITALIA

Ospedale San Raffaele, Milano

Riferimento: Prof. Giampaolo Bianchini

Telefono: 0226436523

Email: bianchini.giampaolo@hsr.it

Localita: Milano

 

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