Evidence map›Paper›PMID 42474572›Full record

Trial reportBreast cancer research and treatment2026

Abemaciclib rechallenge after progression on abemaciclib plus endocrine therapy in patients with hormone receptor-positive HER2-negative metastatic breast cancer: results from the phase II again study (WJOG14220B).

Meiko Nishimura, Takahiro Kogawa, Keiji Sugiyama, Yukinori Ozaki, Yuko Tanabe, Chikako Funasaka, Sasagu Kurozumi, Akiyo Yoshimura, Tsutomu Iwasa, Hitomi Sakai and 10 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Breast cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Review
  2. Article
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

20 authors.

Meiko NishimuraDepartment of Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Kotou-ku, Tokyo, 135-8550, Japan. meiko.nishimura@jfcr.or.jp.ORCID https://orcid.org/0000-0002-7285-9426
Takahiro KogawaDivision of Early Clinical Development for Cancer, Department of Advanced Medical Development, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Kotou-ku, Tokyo, 135-8550, Japan. takahiro.kogawa@jfcr.or.jp.
Keiji SugiyamaDepartment of Medical Oncology, NHO Nagoya Medical Center, Aichi, Japan.
Yukinori OzakiDepartment of Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Kotou-ku, Tokyo, 135-8550, Japan.
Yuko TanabeDepartment of Clinical Oncology, Toranomon Hospital, Tokyo, Japan.
Chikako FunasakaDepartment of Experimental therapeutics, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Sasagu KurozumiDepartment of Breast Surgery, IUHW Narita Hospital, Chiba, Japan.
Akiyo YoshimuraDepartment of Breast Oncology, Aichi Cancer Center, Aichi, Japan.
Tsutomu IwasaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
Hitomi SakaiAdvanced Cancer Translational Research Institute, Showa Medical University, Tokyo, Japan.
Mitsunori MoritaDepartment of Medical Oncology, Hyogo Cancer Center, Akashi, Japan.
Satomi WatanabeDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.
Takaaki FujiiDepartment of General Surgical Science, Graduate School of Medicine, Gunma University, Gunma, Japan.
Mitsugu YamamotoDepartment of Breast Oncology, National Hospital Organization, Hokkaido Cancer Center, Hokkaido, Japan.
Yasushi TsujiDepartment of Medical Oncology, Tonan Hospital, Hokkaido, Japan.
Mitsuo TeradaDepartment of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Takayo OtaDepartment of Breast Medical Oncology, Izumi City General Hospital, Izumi, Japan.
Shinya TokunagaDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Toshimi TakanoDepartment of Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Kotou-ku, Tokyo, 135-8550, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the postMONARCH trial, abemaciclib plus fulvestrant (FUL) yielded a progression-free survival (PFS) of 6.0 months in hormone receptor (HR)-positive HER2-negative metastatic breast cancer patients who progressed after receiving CDK4/6 inhibitor plus endocrine therapy (ET). However, only 8% of these patients had previously received abemaciclib.

methodsThis multicenter, single-arm, phase II study enrolled patients who developed disease progression after abemaciclib plus ET. Patients were switched from aromatase inhibitor (AI)/tamoxifen (TAM) to FUL or from FUL to AI while continuing abemaciclib. The primary endpoint was PFS. The secondary endpoints were the overall response rate (ORR), clinical benefit rate (CBR), chemotherapy-free interval (CFI), overall survival (OS), and safety. Biomarker analysis was performed based on gene alterations.

resultsThis study enrolled 65 patients from June 2021 to November 2023; 64 patients could be evaluated following 1 withdrawal. The median PFS for the 64 patients was 4.2 months (90% CI, 2.8-4.4). The median PFS was 7.1 months (95% CI, 3.9-11.3) in patients who switched from abemaciclib plus AI/TAM to abemaciclib plus FUL (n = 28, 43.8%), whereas it was 2.8 months (95% CI, 1.9-4.2) in patients switching from abemaciclib plus FUL to abemaciclib plus AI (n = 36, 56.3%). The ORR was 8.7% (95% CI, 2.4-20.8), the CBR was 23.9% (95% CI, 12.6-38.8), the CFI was 6.7 months (95% CI, 4.9-11.0), and the OS was 28.7 months (95% CI, 25.4-not estimable [NE]).

conclusionsThe primary endpoint was not met; switching from abemaciclib plus AI/TAM to abemaciclib plus FUL may be a clinically effective option. JRCTS031210129: Date of registration JUNE 2, 2021.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsAdultAgedDisease ProgressionErb-b2 Receptor Tyrosine KinasesFemaleFulvestrantHumansMiddle AgedNeoplasm MetastasisReceptors, EstrogenReceptors, ProgesteroneRetreatmentabemaciclibAminopyridinesBenzimidazolesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFulvestrantReceptors, EstrogenReceptors, ProgesteroneAbemaciclibCDK 4/6 inhibitorHormone receptor-positive HER2 negative breast cancer

Identifiers

PMID42474572
PMCPMC13385166

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.