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
274P - Treatment stratification of non-Hodgkin large B-cell lymphoma patients based on the identification of mutational c-MYC gene
Presenter: Raimkul Karakulov
Session: Poster display session
Resources:
Abstract
275P - Primary central nervous system lymphoma treated with high-dose methotrexate and rituximab: Preliminary results in Vietnam
Presenter: Gia Nguyen Hoang
Session: Poster display session
Resources:
Abstract
276P - Chronic myelod leukemia in chronic phase (CML-CP) with lymphadenopathy at diagnosis: A retrospective analysis
Presenter: GEDALA Veni Prasanna
Session: Poster display session
Resources:
Abstract
277P - Characteristics of BCR-ABL rearrangement variants in Pakistani patients with chronic myeloid leukemia and acute lymphocytic leukemia
Presenter: Zeeshan Ahmed
Session: Poster display session
Resources:
Abstract
278P - A systematic literature review of the cost-effectiveness of treatments, costs, and resource use in patients with Burkitt lymphoma
Presenter: Gautamjeet Mangat
Session: Poster display session
Resources:
Abstract
280P - Risk stratification of CML-CP in a real-world scenario, comparison of S.H.E. with rate of fall of BCR/ABL
Presenter: Kundan Mishra
Session: Poster display session
Resources:
Abstract
281P - Selective depletion of tumour-associated SAMHD1 by HSP90 inhibitors enhances the anti-AML effect of cytarabine
Presenter: Jing Sun
Session: Poster display session
Resources:
Abstract
282P - Inhibition of miR-144 and miR-199 promote myeloma pathogenesis via upregulation of versican and FAK/STAT3 signaling
Presenter: Nidh Gupta
Session: Poster display session
Resources:
Abstract
283P - Effect of study-level factors on treatment-free remission rate in patients with chronic myeloid leukemia: A systematic review and meta-analysis
Presenter: Jinhyun Cho
Session: Poster display session
Resources:
Abstract
284P - Differences in disease characteristics and survival outcomes of follicular lymphoma in young adults and older population: An institutional analysis
Presenter: Shina Goyal
Session: Poster display session
Resources:
Abstract