Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
| Autor: | Frank Hilberg, Miguel Gil, Antonio González-Martín, C Rodriguez-Martin, Ander Urruticoechea, M. J. Escudero, M. Gil-Martin, Raquel Bratos, E Hernandez-Agudo, Juan Antonio Guerra, Raul Marquez, S Vlassak, Ramon Colomer, Miguel Quintela-Fandino |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Oncology
Cancer Research Indoles Receptor ErbB-2 medicine.medical_treatment Phases of clinical research law.invention chemistry.chemical_compound Randomized controlled trial law Antineoplastic Combined Chemotherapy Protocols nintedanib Medicine Prospective Studies Neoadjuvant therapy clinical trial Alanine Transaminase gamma-Glutamyltransferase Middle Aged Neoadjuvant Therapy Treatment Outcome Paclitaxel Nintedanib Female medicine.drug Adult medicine.medical_specialty Neutropenia Cyclophosphamide Maximum Tolerated Dose Short Communication Breast Neoplasms Breast cancer breast cancer Internal medicine Lymphopenia Humans Aspartate Aminotransferases Aged business.industry neoadjuvant phase I medicine.disease Surgery Clinical trial chemistry Doxorubicin HER-2-negative business |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | Introduction: Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer. Methods: Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method). Results: The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide. The dose-limiting toxicity was transaminase elevation. At the RP2D, the dose intensity was ∼100%. The pathologic complete response was 50%. Conclusions: The combination allows the delivery of full-dose intensity, while efficacy seems promising. |
| Databáze: | OpenAIRE |
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