Abstract CT126: Single arm study of neoadjuvant chemotherapy without taxane for BRCAness cases in triple-negative breast cancer
العنوان: | Abstract CT126: Single arm study of neoadjuvant chemotherapy without taxane for BRCAness cases in triple-negative breast cancer |
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المؤلفون: | Ai Ueda, Takashi Ishikawa, Saeko Teraoka, Hiroshi Kaise, Eiichi Sato, Yoko Kawai, Mari Hosonaga, Kimito Yamada, Miki Okazaki, Mari S. Oba |
المصدر: | Cancer Research. 76:CT126-CT126 |
بيانات النشر: | American Association for Cancer Research (AACR), 2016. |
سنة النشر: | 2016 |
مصطلحات موضوعية: | Oncology, Cancer Research, Pathology, medicine.medical_specialty, Taxane, Anthracycline, business.industry, Cancer, medicine.disease, Mitotic spindle checkpoint, Breast cancer, Docetaxel, Internal medicine, medicine, business, Triple-negative breast cancer, Epirubicin, medicine.drug |
الوصف: | BACKGROUND: BRCA1 impaired cancers are sensitive to DNA damage. This is associated with the defective homologous recombination (HR) pathway in these tumors. In contrast, these tumors are resistant to mitotic poisons, because BRCA1 protein activates the mitotic spindle checkpoint and triggers apoptosis in microtubule damage. Both preclinical evidence and clinical evidence have shown that the single-agent taxane is not active for BRCA1 mutated breast cancers. It is reported that BRCA1 function may be impaired in approximately 60% of triple negative breast cancer (TNBC) without mutation. This is called ‘BRCAness’. Previous studies have demonstrated that BRCAness identified tumors with HR deficiency. Thus, taxane may not be necessary for all TNBC cases, although combined treatments of anthracycline and taxane are standard at present. STUDY PROTOCOL: We have launched a single arm study of neoadjuvant chemotherapy (NAC) for TNBC to confirm that taxane is unnecessary in BRCAness cases. For the study protocol, TNBC cases requiring NAC are enrolled. Four cycles of an anthracycline-based regimen (FEC 100 or dose-dense EC) are started and BRCAness is examined simultaneously in core-needle specimens. BRCAness is determined by Multiple Ligation-dependent Probe Amplification (MLPA) methods (FALCO Biosystems), which consist of 2 steps. These include copy number analysis in 34 loci specific to BRCA1 mutant and scoring with prediction analysis for microarray. If BRCAness is determined by MLPA, surgery is performed without proceeding to taxane. The primary endpoint is a pathological complete response (pCR) in surgical specimens. The expected pCR and threshold pCR are estimated at 55% and 40%, respectively, based on our previous randomized phase II trial comparing docetaxel plus cyclophosphamide with epirubicin plus cyclophosphamide followed by docetaxel for hormone receptor-negative breast cancer (Ishikawa T. ASCO 2013). With a one-sided significance of 5%, 70 BRCA cases are required. This study was approved in September 2015 and has been started. Interim analysis is planned when 30 cases are completed. Citation Format: Takashi Ishikawa, Saeko Teraoka, Hiroshi Kaise, Kimito Yamada, Mari Hosonaga, Ai Ueda, Yoko Kawai, Miki Okazaki, Mari S. Oba, Eiichi Sato. Single arm study of neoadjuvant chemotherapy without taxane for BRCAness cases in triple-negative breast cancer. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT126. |
تدمد: | 1538-7445 0008-5472 |
DOI: | 10.1158/1538-7445.am2016-ct126 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::92872be47e1127732bf7f2fccde7608e https://doi.org/10.1158/1538-7445.am2016-ct126 |
رقم الانضمام: | edsair.doi...........92872be47e1127732bf7f2fccde7608e |
قاعدة البيانات: | OpenAIRE |
تدمد: | 15387445 00085472 |
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DOI: | 10.1158/1538-7445.am2016-ct126 |