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
448P - Incidence and severity of chemotherapy induced peripheral neuropathy in geriatric population who are receiving chemotherapy
Presenter: Alekhya Mandepudi
Session: Poster display session
Resources:
Abstract
449P - Utility of screening tool for assessment of chemotherapy induced peripheral neuropathy in cancer patients
Presenter: PRUTHVI Paibhavi
Session: Poster display session
Resources:
Abstract
450P - Supportive care to control nausea and dizziness in malignant tumours: A systematic review
Presenter: Rainer Spiegel
Session: Poster display session
Resources:
Abstract
451P - The safety of ramucirumab without H1-antihistamines as a premedication in patients with solid cancers: A retrospective study
Presenter: Nobuhiro Hattori
Session: Poster display session
Resources:
Abstract
452P - Expression of erythropoietin receptor in patient with anemia related chemotherapy and its correlation with absolute reticulocyte count
Presenter: Irza Wahid
Session: Poster display session
Resources:
Abstract
453P - Body mass index did not correlate with short term overall survival in breast cancers
Presenter: Jungsun Lee
Session: Poster display session
Resources:
Abstract
454P - Predictors of severity and comparison of CTCAE V3.0 vs V4.3 in assessing chemotherapy induced extravasation injuries
Presenter: Sangana Reddy
Session: Poster display session
Resources:
Abstract
455P - Assessment of nutritional status and quality of life among cancer patients undergoing chemotherapy
Presenter: Sri Prathima
Session: Poster display session
Resources:
Abstract
456P - Use of gamma irradiated bone allografts in treatment of various bone tumours
Presenter: Anchal Mishra
Session: Poster display session
Resources:
Abstract
457P - The prevalence of vitamin D deficiency in Thai cancer patients, its dynamics and association with cancer survival
Presenter: Chavapon Ngokngarm
Session: Poster display session
Resources:
Abstract