Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer

Summary

Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.

Timeline

Start

2012-04-17

Primary completion

2014-06-01

Completion

2018-05-27

Outcome

Missed primary endpoint

paper Despite failing to confirm an RCB III rate ≤16% in nab-Paclitaxel-treated patients PMID 28701571 ↗

Publications

• Results Martin M, Chacon JI, Anton A, Plazaola A, Garcia-Martinez E, Segui MA, Sanchez-Rovira P, Palacios J, Calvo L, Esteban C, Espinosa E, Barnadas A, Batista N, Guerrero A, Munoz M, Romio E, Rodriguez-Martin C, Caballero R, Casas MI, Rojo F, Carrasco E, Antolin S. Neoadjuvant Therapy with Weekly Nanoparticle Albumin-Bound Paclitaxel for Luminal Early Breast Cancer Patients: Results from the NABRAX Study (GEICAM/2011-02), a Multicenter, Non-Randomized, Phase II Trial, with a Companion Biomarker Analysis. Oncologist. 2017 Nov;22(11):1301-1308. doi: 10.1634/theoncologist.2017-0052. Epub 2017 Jul 12.

Drugs

Indications