Open label, randomized clinical trial of standard neoadjuvant chemotherapy with paclitaxel followed by FEC (T-FEC) versus the combination of paclitaxel and RAD001 followed by FEC (TR-FEC) in women with triple receptor-negative breast cancer (TNBC)
| Autor: | William Fraser Symmans, Shana L. Palla, Sharon H. Giordano, Nuhad K. Ibrahim, Gabriel N. Hortobagyi, Funda Meric-Bernstam, Abenaa M. Brewster, P. R. Flores, D. J. Crawford, V. Valero, James L. Murray, Marjorie C. Green, Kimberly Koenig, S. L. Moulder, Lajos Pusztai, Aman U. Buzdar, Jennifer K. Litton, Gordon B. Mills, Mark J. Dryden, A. M. Gonzalez-Angulo |
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| Rok vydání: | 2011 |
| Předmět: |
Oncology
Cancer Research Pathology medicine.medical_specialty Chemotherapy Cyclophosphamide business.industry medicine.medical_treatment Phases of clinical research medicine.disease Targeted therapy chemistry.chemical_compound Breast cancer Paclitaxel chemistry Internal medicine Clinical endpoint Medicine business medicine.drug Epirubicin |
| Zdroj: | Journal of Clinical Oncology. 29:1016-1016 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2011.29.15_suppl.1016 |
| Popis: | 1016 Background: TNBC is an aggressive disease and the only subtype with no specific targeted therapy. PI3K pathway activation occurs frequently in TNBC and confers susceptibility to mTOR inhibitors as RAD001. mTOR inhibition synergistically enhances taxane-induced cytotoxicity in breast cancer cells including TNBC in vitro and in vivo. Methods: We conducted a single institution phase II study in patients (pts) with primary TNBC randomized to T-FEC (paclitaxel 80mg/m2 IV weekly for 12 weeks, followed by 5FU 500mg/m2, epirubicin 100mg/m2, and cyclophosphamide 500mg/m2 every 3 weeks for 4 cycles) vs TR-FEC (paclitaxel 80mg/m2 IV and RAD001 30mg PO weekly for 12 weeks, followed by 5FU 500mg/m2, epirubicin 100mg/m2, and cyclophosphamide 500mg/m2 IV every 3 weeks for 4 cycles). Clinical endpoints included 12-week response rate (12wk RR, complete or partial response), pathological complete response (pCR), and toxicity. Tumor samples were collected to assess molecular changes in the PI3K pathway, at baseline, 48... |
| Databáze: | OpenAIRE |
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