Evidence map›Paper›PMID 38771995›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Final Results of RIGHT Choice: Ribociclib Plus Endocrine Therapy Versus Combination Chemotherapy in Premenopausal Women With Clinically Aggressive Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer.

Yen-Shen Lu, Eznal Izwadi Bin Mohd Mahidin, Hamdy Azim, Yesim Eralp, Yoon Sim Yap, Seock-Ah Im, Julie Rihani, Erhan Gokmen, Ahmed El Bastawisy, Nuri Karadurmus and 12 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  13. Expert consensus on optimal management of liver-related adverse events during CDK4/6 inhibitor therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Yen-Shen LuNational Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0001-7461-1291
Eznal Izwadi Bin Mohd MahidinHospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Hamdy AzimSchool of Medicine, Cairo University, Cairo, Egypt.
Yesim EralpAcıbadem Research Institute of Senology, Acıbadem University, Istanbul, Turkey.ORCID 0000-0001-9603-4755
Yoon Sim YapNational Cancer Centre Singapore, Singapore.ORCID 0000-0002-0347-5066
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-5396-6533
Julie RihaniIndependent Patient Advocate, Amman, Jordan.
Erhan GokmenEge University Faculty of Medicine, Izmir, Turkey.
Ahmed El BastawisyNational Cancer Institute, Cairo University, Giza, Egypt.ORCID 0000-0002-5862-5463
Nuri KaradurmusGülhane Education and Research Hospital, University of Health Sciences, Ankara, Turkey.
Yueh Ni LimSarawak General Hospital, Kuching, Sarawak, Malaysia.
Chun Sen LimHospital Sultan Ismail, Johor Bharu, Johor Darul Ta'zim, Malaysia.
Le Thanh DucNational Cancer Hospital, Hanoi, Vietnam.
Wei-Pang ChungNational Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
K Govind BabuHCG Curie Centre of Oncology and Kidwai Memorial Institute of Oncology, Bangalore, India.ORCID 0000-0002-1303-2226
Konstantin PenkovPrivate Medical Institution Euromedservice, St Petersburg, Russian Federation.
James BowlesNovartis Pharma AG, Basel, Switzerland.
Teresa Delgar AlfaroNovartis Pharma AG, Basel, Switzerland.
Jiwen WuNovartis Pharmaceuticals Corporation, East Hanover, NJ.
Melissa GaoNovartis Pharma AG, Basel, Switzerland.
Khemaies SlimaneNovartis Pharma AG, Basel, Switzerland.
Nagi S El SaghirAmerican University of Beirut Medical Center, Beirut, Lebanon.ORCID 0000-0001-9612-4224

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA head-to-head comparison of efficacy between a cyclin-dependent kinase 4/6 inhibitor plus endocrine therapy (ET) versus combination chemotherapy (CT) has never been reported in patients with clinically aggressive hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC).

methodsIn this open-label, multicenter, randomized phase II trial, pre/perimenopausal women with clinically aggressive HR+/HER2- ABC were randomly assigned 1:1 to first-line ribociclib (600 mg once daily; 3 weeks on, 1 week off) plus letrozole/anastrozole and goserelin or investigator's choice of combination CT (docetaxel plus capecitabine, paclitaxel plus gemcitabine, or capecitabine plus vinorelbine). The primary end point was progression-free survival (PFS).

resultsAmong 222 patients randomly assigned to ribociclib plus ET (n = 112) or combination CT (n = 110), 150 (67.6%) had symptomatic visceral metastases, 41 (18.5%) had rapid disease progression per investigator's judgment, and 31 (14.0%) had symptomatic nonvisceral disease. Overall, 106 (47.7%) patients had investigator-assessed visceral crisis. The median follow-up time was 37.0 months. At data cutoff, 31.3% (ribociclib arm) and 15.5% (CT arm) of patients had completed study treatment and transitioned to post-trial access. The median PFS was 21.8 months (ribociclib plus ET; [95% CI, 17.4 to 26.7]) and 12.8 months (combination CT; [95% CI, 10.1 to 18.4); hazard ratio, 0.61 [95% CI, 0.43 to 0.87];

conclusionFirst-line ribociclib plus ET showed a significant PFS benefit, similar response rates, and better tolerability over combination CT in patients with clinically aggressive HR+/HER2- ABC.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesPurinesReceptors, EstrogenReceptors, ProgesteroneAdultCyclin-Dependent Kinase 4FemaleHumansMiddle AgedPremenopauseProgression-Free SurvivalAminopyridinesCyclin-Dependent Kinase 4ERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPurinesReceptors, EstrogenReceptors, Progesteroneribociclib

Identifiers

PMID38771995
PMCPMC11315404

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.