Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study

• Published in: The lancet oncology 2011-04, Vol.12 (4), p.369-376
• Main Authors: Martin, Miguel, Prof, Roche, Henri, Prof, Pinter, Tamas, MD, Crown, John, Prof, Kennedy, M John, MB, Provencher, Louise, MD, Priou, Frank, MD, Eiermann, Wolfgang, Prof, Adrover, Encarna, MD, Lang, Istvan, Prof, Ramos, Manuel, MD, Latreille, Jean, FRCPC, Jagiełło-Gruszfeld, Agnieszka, MD, Pienkowski, Tadeusz, MD, Alba, Emilio, MD, Snyder, Raymond, MMed, Almel, Sachin, MD, Rolski, Janusz, MD, Munoz, Montserrat, MD, Moroose, Rebecca, MD, Hurvitz, Sara, MD, Baños, Ana, BSc, Adewoye, Henry, MD, Hei, Yong-Jiang, MD, Lindsay, Mary-Ann, PhD, Rupin, Matthieu, MSc, Cabaribere, David, MSc, Lemmerick, Yasmin, MBA, Mackey, John R, Prof
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Double-Blind Method; Female; Hematology, Oncology and Palliative Medicine; Humans; Indoles - administration & dosage; Indoles - therapeutic use; Middle Aged; Neoplasm Metastasis - drug therapy; Neoplasm Recurrence, Local - drug therapy; Niacinamide - administration & dosage; Niacinamide - analogs & derivatives; Niacinamide - therapeutic use; Paclitaxel - administration & dosage; Paclitaxel - therapeutic use; Receptor, ErbB-2 - analysis
• ISSN: 1470-2045; 1474-5488
• DOI: 10.1016/S1470-2045(11)70037-7

Summary Background Vascular endothelial growth factor (VEGF) has a crucial role in angiogenesis, and is a valid target in metastatic breast cancer. Motesanib is an investigational oral inhibitor of VEGF receptors. We aimed to determine whether treatment with motesanib plus paclitaxel is better than placebo plus paclitaxel in patients with HER2-negative locally recurrent or metastatic breast cancer. Methods Between Dec 1, 2006, and July 4, 2008, patients with untreated HER2-negative metastatic breast cancer were randomly assigned (using a randomisation list created by personnel not associated with the study) in a 1:1:1 ratio to paclitaxel (90 mg/m2 on days 1, 8, and 15 every 3 weeks) plus either masked motesanib 125 mg orally once per day (n=91), masked placebo orally once per day (n=94), or open-label bevacizumab 10 mg/kg intravenously on days 1 and 15 of each 28-day cycle (n=97), after stratification according to adjuvant or neoadjuvant chemotherapy (taxane-containing regimens vs other regimens vs none), number of metastatic sites (