Abstract 35TiP
Background
Approximately half of all patients (pts) with breast cancer in Asia-Pacific (∼42%) and the Middle East (∼50%) are under 50 years of age. In routine clinical practice, a substantial proportion of women aged <50 years with endocrine-responsive ABC are initially treated with cytotoxic chemotherapy (CT). Phase 3 trials have shown higher response rates and longer progression-free survival (PFS) and overall survival with endocrine therapy (ET) plus a cyclin-dependent kinase (CDK) 4/6 inhibitor than with ET monotherapy; however, clinical trials in pre-/perimenopausal pts with ABC are needed to assess the efficacy of ET plus a CDK4/6 inhibitor versus CT when CT is considered.
Trial design
The RIGHT choice study is a randomized, open-label phase II study aiming to enroll 222 pre-/ perimenopausal women aged 18–59 years with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2–) ABC across 58 sites in 13 Asian/Middle Eastern countries and Russia (11 enrolled as of June 13, 2019). Pts must have advanced disease not amenable to curative therapy, with symptomatic visceral metastases or impending visceral compromise, rapid disease progression, or markedly symptomatic nonvisceral disease for which combination CT is usually indicated. Pts must have had no prior systemic ET or CT for advanced disease except luteinizing hormone-releasing hormone agonist, and have an ECOG performance score ≤2. Tumors must be estrogen receptor-positive in ≥ 10% of cells or have an Allred score ≥5, per local laboratory testing. Postmenopausal, pregnant, or lactating women will not be included. Pts will be randomized to either 600 mg ribociclib (3 wks on/1 wk off) plus goserelin and letrozole or anastrozole, or to investigator’s choice of docetaxel + capecitabine, paclitaxel + gemcitabine, or capecitabine + vinorelbine. The primary endpoint is PFS. Secondary endpoints include time to treatment failure, overall response rate, clinical benefit rate, time to response, overall survival, patient-reported outcomes, and safety. Healthcare resource utilization will be an exploratory endpoint.
Clinical trial identification
NCT03839823.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
Y-S. Lu: Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution): Roche; Speaker Bureau / Expert testimony: Elsai; Speaker Bureau / Expert testimony: EuroPharma; Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution): Merck; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Odonate. S.S. Malwinder: Speaker Bureau / Expert testimony, Research grant / Funding (self): AstraZeneca; Speaker Bureau / Expert testimony: Eli Lilly; Speaker Bureau / Expert testimony: Merck; Speaker Bureau / Expert testimony, Research grant / Funding (self): Novartis; Speaker Bureau / Expert testimony: Pfizer; Research grant / Funding (self): Asian Pharmaceuticals; Leadership role: Malaysian Oncology Society. H. Azim: Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen; Advisory / Consultancy: Hekma; Advisory / Consultancy: Bayer. Y. Eralp: Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Nobel. S-A. Im: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Advisory / Consultancy: Amgen; Advisory / Consultancy: Elsai; Advisory / Consultancy: Hanmi. Y.S. Yap: Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Eisai; Honoraria (self), Travel / Accommodation / Expenses: Eli Lilly; Honoraria (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Travel / Accommodation / Expenses: Roche. T. Delgar Alfaro: Full / Part-time employment: Novartis. M. Gao: Full / Part-time employment: Novartis. N.S. El Saghir: Honoraria (self): Eli Lilly; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Roche.
Resources from the same session
381P - XKR8 is a promising potential prognostic marker in glioblastoma multiforme patients
Presenter: Kristina Havrysh
Session: Poster display session
Resources:
Abstract
383P - Screening of prognostic molecular biomarker for resectable pancreatic cancer
Presenter: Yonggang Peng
Session: Poster display session
Resources:
Abstract
384P - Prevalence of abnormal microsatellite instability test among ovary and endometrial cancer patients
Presenter: Min Kyu Kim
Session: Poster display session
Resources:
Abstract
385P - Identifying CASP8 polymorphisms associated with breast cancer risk in an Iranian population
Presenter: Alireza Pasdar
Session: Poster display session
Resources:
Abstract
386P - Unusual folding of NaPi2b transporter extramembrane domain 4 during malignant transformation
Presenter: Leysan Minigulova
Session: Poster display session
Resources:
Abstract
387P - 5-years conditional disease free survival and overall survival for breast cancer patients in South Korea
Presenter: Jee hyun Ahn
Session: Poster display session
Resources:
Abstract
388P - To identify circulating tumour cells by machine learning approach
Presenter: Yuebin Liang
Session: Poster display session
Resources:
Abstract
389P - The establishment of patient-derived organoid models and drug response of resectable non-small cell lung cancer
Presenter: Jing-Hua Chen
Session: Poster display session
Resources:
Abstract
395P - Filipinos and lung cancer: An infodemiological assessment using Google trends from 2009 to 2019
Presenter: Lance Isidore Catedral
Session: Poster display session
Resources:
Abstract
396P - Determinants of visiting a referral hospital for cervical cancer screening at Uganda Cancer Institute
Presenter: Collins Mpamani
Session: Poster display session
Resources:
Abstract