دورية أكاديمية
Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy endocrine therapy alone in patients with HR+/HER2− early breast cancer
| العنوان: | Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy endocrine therapy alone in patients with HR+/HER2− early breast cancer |
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| المؤلفون: | Dennis J. Slamon, Peter A. Fasching, Sara Hurvitz, Stephen Chia, John Crown, Miguel Martín, Carlos H. Barrios, Aditya Bardia, Seock-Ah Im, Denise A. Yardley, Michael Untch, Chiun-Sheng Huang, Daniil Stroyakovskiy, Binghe Xu, Rebecca L. Moroose, Sherene Loi, Frances Visco, Valerie Bee-Munteanu, Karen Afenjar, Rodrigo Fresco, Tetiana Taran, Arunava Chakravartty, Juan Pablo Zarate, Agnes Lteif, Gabriel N. Hortobagyi |
| المصدر: | Therapeutic Advances in Medical Oncology, Vol 15 (2023) |
| بيانات النشر: | SAGE Publishing, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| مصطلحات موضوعية: | Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: | Background: Ribociclib has demonstrated a statistically significant overall survival benefit in pre- and postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer. New Adjuvant Trial with Ribociclib [LEE011] (NATALEE) is a trial evaluating the efficacy and safety of adjuvant ribociclib plus endocrine therapy (ET) versus ET alone in patients with HR+/HER2− early nonmetastatic breast cancer (EBC). Methods/design: NATALEE is a multicenter, randomized, open-label, Phase III trial in patients with HR+/HER2− EBC. Eligible patients include women, regardless of menopausal status, and men aged ⩾18 years. Select patients with stage IIA, stage IIB, or stage III disease (per the anatomic classification in the AJCC Cancer Staging Manual , 8th edition) with an initial diagnosis ⩽18 months prior to randomization are eligible. Patients receiving standard (neo)adjuvant ET are eligible if treatment was initiated ⩽12 months before randomization. Patients undergo 1:1 randomization to ribociclib 400 mg/day (3 weeks on/1 week off) +ET (letrozole 2.5 mg/day or anastrozole 1 mg/day [investigator’s discretion] plus goserelin [men or premenopausal women]) or ET alone. Ribociclib treatment duration is 36 months; ET treatment duration is ⩾60 months. The primary end point is invasive disease-free survival. Discussion: The 36-month treatment duration of ribociclib in NATALEE is extended compared with that in other adjuvant cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor trials and is intended to maximize efficacy due to longer duration of CDK4/6 inhibition. Compared with the 600-mg/day dose used in advanced breast cancer, the reduced ribociclib dose used in NATALEE may improve tolerability while maintaining efficacy. NATALEE includes the broadest population of patients with HR+/HER2− EBC of any Phase III trial currently evaluating adjuvant CDK4/6 inhibitor treatment. Trial registration: ClinicalTrials.gov identifier: NCT03701334 ( https://clinicaltrials.gov/ct2/show/NCT03701334Test ) |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1758-8359 17588359 |
| العلاقة: | https://doaj.org/toc/1758-8359Test |
| DOI: | 10.1177/17588359231178125 |
| الوصول الحر: | https://doaj.org/article/73d02bee3f9e4dc6a76bef48c3ed8ce0Test |
| رقم الانضمام: | edsdoj.73d02bee3f9e4dc6a76bef48c3ed8ce0 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 17588359 |
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| DOI: | 10.1177/17588359231178125 |