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
144P - Severe hypovitaminosis D in metastatic gastric cancer patients from the Northern and Southern hemispheres: Data from the EXPAND phase III trial
Presenter: Radka Obermannova
Session: Poster display session
Resources:
Abstract
145P - Role of Glasgow prognostic score in chemo-naïve patients with advanced biliary tract cancer and good performance status
Presenter: Toshikazu Moriwaki
Session: Poster display session
Resources:
Abstract
146P - Anatomic versus non-anatomic resection for hepatocellular carcinoma: A meta-analysis of high-quality studies
Presenter: Bin Zhang
Session: Poster display session
Resources:
Abstract
147P - Clinical outcomes of proximal gastrectomy versus total gastrectomy for locally advanced proximal gastric cancer: a propensity score matching analysis
Presenter: Yingtai Chen
Session: Poster display session
Resources:
Abstract
148P - Efficacy of capecitabine and oxaliplatin versus S-1 as adjuvant chemotherapy in gastric cancer after D2 lymph node dissection according to lymph node ratio and N stage
Presenter: Seunghwan Lee
Session: Poster display session
Resources:
Abstract
150P - A Phase Ib Study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction
Presenter: Yee Chao
Session: Poster display session
Resources:
Abstract
151P - Gene expression profiling for a better understanding of gastric cancer: From the perspective of metabolic rearrangement
Presenter: Midie Xu
Session: Poster display session
Resources:
Abstract
152P - Long-term outcomes of three-dimensional conformal radiotherapy-based and intensity-modulated radiotherapy-based concurrent chemoradiotherapy in patients with thoracic esophageal squamous cell carcinoma
Presenter: Chia-Lun Chang
Session: Poster display session
Resources:
Abstract
153P - Exosomal LINC00174 facilitates epithelial-mesenchymal transition in residual hepatocellular carcinoma after insufficient radiofrequency ablation by regulating c-JUN/MYCBP/c-Myc axis
Presenter: Dening Ma
Session: Poster display session
Resources:
Abstract
154P - Genetic characteristics of participants in the Australian Pancreatic Screening Study
Presenter: Krithika Murali
Session: Poster display session
Resources:
Abstract