214TiP - VENTANA (SOLTI-1501): Antiproliferative Effect of the Addition of Oral Metronomic Vinorelbine to Endocrine Therapy in Luminal/HER2-negative Early B...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Breast Cancer
Presenter Barbara Adamo
Citation Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362
Authors B. Adamo1, J.A. Perez Fidalgo2, E. Ciruelos3, M. Vidal1, S. Blanch4, A. Lopez5, P. Gomez Pardo6, L. Murillo7, K. Amillano8, N. Martínez Jañez9, X. Gonzalez10, J. Canes Ruiz11, A. Prat1
  • 1Medical Oncology  , Hospital Clínic de Barcelona  , 8036 - Barcelona/ES
  • 2Medical Oncology  , Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 3Medical Oncology  , Hospital Universitario 12 De Octubre, 28041 - Madrid/ES
  • 4Medical Oncology  , Fundación Instituto Valenciano de Oncología, Valencia/ES
  • 5Medical Oncology  , Hospital de León, Leon/ES
  • 6Medical Oncology  , Vall d'Hebron University Hospital, 8035 - Barcelona/ES
  • 7Medical Oncology  , Hospital Clínico Universitario Lozano Blesa, Zaragoza/ES
  • 8Medical Oncology  , Hospital Universitari Sant Joan de Reus, Reus/ES
  • 9Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid/ES
  • 10Medical Oncology  , Hospital Universitario Quirón Dexeus, 08028 - Barcelona/ES
  • 11Scientific, SOLTI Breast Cancer Research Group, 08008 - Barcelona/ES

Abstract

Background

The cornerstone of luminal breast tumors treatment both in early and advanced settings is endocrine therapy (ET). Although extended adjuvant ET has demonstrated benefit, a significant percentage of patients relapse. In previous studies, the combination of ET with CDK4/6 inhibitors has shown unprecedented efficacy suggesting that inhibition of the cell cycle in combination with ET is a strategy to keep exploring. The efficacy and safety of metronomic VNB have been confirmed in preclinical and clinical studies and it is now considered a multi-mechanisms of action therapy that could offer advantages when combined with other drugs. VENTANA study is a “window-of-opportunity” trial designed to explore whether, similarly to CDK4/6 inhibitors, oral metronomic VNB in combination with endocrine therapy induces a superior antiproliferative effect than ET alone. We hypothesize that the synergistic biological effect of the combined treatment could be an alternative to CDK4/6 inhibitors in the treatment of luminal breast cancer patients.

Trial design

Pts are randomized (1:1:1) to receive LET 2.5mg daily, oral VNB 50mg 3 days a week, or the combination. After 3 weeks of treatment, pts undergo surgery. Pre- and post-treatment (surgical) samples will be analyzed for gene expression. The primary objective is to test if oral metronomic VNB and LET induce a superior anti-proliferative effect than either drug alone in pts with early BC defined as Luminal by PAM50. This will be evaluated by the expression of 11 proliferative genes contained in the PAM50 subtype predictor (BIRC5, CCNB1, CDC20, CDCA1, CEP55, KNTC2, MKI67, PTTG1, RRM2, TYMS and UBE2C) as surrogate signature biomarker of its anticancer activity. In addition, 560 BC-related gene signatures will also be analyzed. Enrollment started in July 2016 in 10 sites across Spain. To date, 47 patients have been included. We expect to report full study results by Spring 2018.

Clinical trial identification

NCT02802748

Legal entity responsible for the study

SOLTI Breast Cancer Research Group

Funding

Pierre Fabre

Disclosure

All authors have declared no conflicts of interest.