Evidence map›Paper›PMID 33149768›Full record

ArticleTherapeutic advances in medical oncology2020

MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study.

Qing Yuan Zhang, Tao Sun, Yong Mei Yin, Hui Ping Li, Min Yan, Zhong Sheng Tong, Christina P Oppermann, Yun Peng Liu, Romulo Costa, Man Li and 15 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in medical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06341283 (A Retrospective Real-world Study of Efficacy, Safety, and Economic Assessment of Abemaciclib Tablets Based on Hospital Information System), which is not on this map. Cited by 73 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 17 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.

NCT06341283 unknown statusnot on this mapstarted 2024, after this paper: background citation

A Retrospective Real-world Study of Efficacy, Safety, and Economic Assessment of Abemaciclib Tablets Based on Hospital Information System(HIS) in Hormone Recepter Positive(HR+) Breast Cancer Patients

TypeobservationalSponsorThe Affiliated Hospital of Qingdao UniversityRan2024 to 2025Enrolled200ConditionsBreast Cancer, Neoplasms, Breast DiseasesArmsAbemaciclib and Letrozole/Anastrozole, Letrozole or Anastrozole, Abemaciclib and Fulvestrant, Fulvestrant
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 17 syntheses or guidelines pooled it.

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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

Qing Yuan ZhangDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Tao SunDepartment of Medical Oncology, Cancer Hospital of China Medical University/ Liaoning Cancer Hospital, Shenyang, China.
Yong Mei YinDepartment of Oncology, Jiangsu Province Hospital, Nanjing, China.
Hui Ping LiDepartment of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Min YanDepartment of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Zhong Sheng TongDepartment of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Christina P OppermannCentro de Pesquisa Clínica de Oncologia e Hematologia, Hospital Mãe de Deus/AESC, Porto Alegre, Brazil.
Yun Peng LiuDepartment of Medical Oncology, First Affiliated Hospital of China Medical University,Shenyang, China.
Romulo CostaOncologia Clínica, Instituto do Cancer do Estado de São Paulo - ICESP, São Paulo, Brazil.
Man LiDepartment of Oncology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
Ying ChengDepartment of Medical Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun, China.
Qu Chang OuyangDepartment of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha, China.
Xi ChenDepartment of Medical Oncology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.
Ning LiaoDepartment of Breast Cancer, Guangdong General Hospital, Guangzhou, China.
Xin Hong WuDepartment of Breast Cancer, Hubei Cancer Hospital, Wuhan, China.
Xiao Jia WangDepartment of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Ji Feng FengDepartment of Medical Oncology, Jiangsu Province Cancer Hospital, Nanjing, China.
Roberto HeggDepartment of Gynecology and Obstetrics, Hospital Pérola Byington and FMUSP, São Paulo-SP, Brazil.
G B KanakasettyDepartment of Medical Oncology, HCG Hospitals and Kidwai Memorial Institute of Oncology, Bangalore, India.
Maria A Coccia-PortugalClinical Trial Department, Eastleigh Breast Care Center, Pretoria, South Africa.
Ru Bing HanEli Lilly and Company, Shanghai, China.
Yi LuEli Lilly and Company, Indianapolis, IN, United States of America.ORCID https://orcid.org/0000-0003-2252-9813
Hai Dong ChiEli Lilly and Company, Shanghai, China.
Ze Fei JiangDepartment of Breast Cancer, Fifth Medical Center of Chinese PLA General Hospital, 100 West Fourth Ring Middle Road, Beijing 100071, China.
Xi Chun HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai 200032, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare the efficacy, safety, and tolerability of abemaciclib plus endocrine therapy (ET)

methodsThis randomized, double-blind, phase III study was conducted between 9 December 2016 and 29 March 2019. Postmenopausal women with HR-positive, HER2-negative ABC with no prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) received abemaciclib (150 mg twice daily) or placebo plus: anastrozole (1 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg per label) (cohort B). The primary endpoint was progression-free survival (PFS) in cohort A, analyzed using the stratified log-rank test. Secondary endpoints were PFS in cohort B (key secondary endpoint), objective response rate (ORR), and safety. This interim analysis was planned after 119 PFS events in cohort A.

resultsIn cohort A, 207 patients were randomly assigned to the abemaciclib arm and 99 to the placebo arm. Abemaciclib significantly improved PFS

conclusionThe addition of abemaciclib to ET demonstrated significant and clinically meaningful improvement in PFS and ORR, without new safety signals observed in this population.

Indexed as

abemaciclibaromatase inhibitorsbreast neoplasmscyclin-dependent kinase 4cyclin-dependent kinase 6fulvestrant

Identifiers

PMID33149768
PMCPMC7586037

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Registered trials

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.