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Poster display session

4914 - Neoadjuvant eribulin following anthracycline and taxane in triple negative breast cancer (HOPE): a multicenter, two stage, phase II trial

Date

11 Sep 2017

Session

Poster display session

Presenters

Serena Di Cosimo

Citation

Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362

Authors

S. Di Cosimo1, N. Laverde2, M.E. Cazzaniga3, D. Generali4, G.V. Bianchi5, E. Tagliabue6, V. Torri7, F. Crippa8, B. Paolini9, G. Scaperrotta10, A. Gulino11, C. Tripodo11, M.P. Colombo12, S. Folli13, F.G. de Braud14

Author affiliations

  • 1 Biomarker Unit, Dipartimento Di Ricerca Applicata E Sviluppo Tecnologico (drast), Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Department Of Oncology, ASST Fatebenefratelli Sacco, Milan/IT
  • 3 Department Of Oncology, Azienda Ospedaliera San Gerardo, 20900 - Monza/IT
  • 4 Breast Cancer Unit And Molecular Therapy Unit, Istituti Ospitalieri di Cremona, 26100 - Cremona/IT
  • 5 Division Of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 6 Trial Center, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 7 Statistics, Mario Negri, 20133 - Milan/IT
  • 8 Nuclear Medicine And Pet Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 9 Department Of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan/IT
  • 10 Breast Imaging Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 11 Tumor Immunology Unit, Palermo University School of Medicine, 90100 - Palermo/IT
  • 12 Experimental Oncology And Molecular Medicine, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 13 Breast Surgery Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 14 Division Of Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
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Resources

Abstract 4914

Background

Neoadjuvant chemotherapy for triple negative breast cancer (TNBC) patients (pts) is mostly based on anthracycline and taxane (AT). The microtubule dynamics inhibitor eribulin mesylate (E) has been proved to increase survival in heavily pretreated metastatic breast cancer pts. We argue that sequential AT and E would benefit also non-metastatic TNBC pts.

Methods

Pts with primary TNBC>2 cm received doxorubicin 60 mg/m2+paclitaxel 200 mg/m2 day 1, q 21 for 4 cycles, followed by E 1.4 mg/m2 days 1,8 q 21 for 4 cycles. The primary endpoint was the pathological complete response (pCR) rate; secondary endpoints included clinical response rate by RECIST 1.1, metabolic response by EORTC criteria, safety profile and biomarker analysis. Sample size was estimated to detect a 40% pCR, with 20% for a minimal hypothesis. With a type I error of 0.05 and a statistical power of 80%, 13 patients were to be initially enrolled. Observation of ≥ 4 pCR would justify continuation of accrual up to 43 pts.

Results

Thirteen pts were enrolled. The combination was safe with mostly G1/2 toxicities. The only G ≥ 3 event was neutropenia, which was related to AT in 4 pts and to E in 2 pts. An analysis of the degree of response by imaging was feasible in 11 pts. Overall 6/11 (54%) pts achieved a partial response after AT; of note 3/5 (27%) AT-unresponsive pts responded to E, 1 had stable disease and 1 pt definitely progressed. FDG PET/CT scans were available in 12 pts after AT and in 10 pts after 2 cycles of E. Median SUVmax values were 13, 3, and 2 at baseline, after AT and after E, respectively. Of the 4 pts with complete metabolic response (2 after AT and 2 after E), 2 achieved pCR at surgery. Immunostaining of paired pre- and post-treatment tumor bioptic specimens revealed reduction of beta-catenin, cyclin D and c-myc expression in the absence of n-cadherin modulation. The trial was halted because of the unmet primary endopoint (3 pCR).

Conclusions

Despite an unmet primary endpoint, E showed clinical and biological activity in TNBC pts. The observed modulation of beta-catenin pathway core proteins, purportedly outside the domain of epithelial mesenchymal transition, claims for further investigation and for the refinement in the definition of the clinical endpoints.

Clinical trial identification

EUDRACT: RELEASE: November 2012

Legal entity responsible for the study

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Funding

Eisai

Disclosure

All authors have declared no conflicts of interest.

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