Evidence map›Paper›PMID 40841781›Full record

Trial reportBreast cancer (Tokyo, Japan)2025

Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis.

Masato Takahashi, Hiroyuki Yasojima, Tomofumi Osako, Kenichi Inoue, Masahiro Kawashima, Hideki Maeda, Mitsuya Ito, Yasuaki Sagara, Kan Yonemori, Masaya Hattori and 4 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04735367 (Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04735367 completednot on this map

Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole

TypeobservationalSponsorPfizerRan2021 to 2023Enrolled42ConditionsBreast CancerArmspalbociclib plus letrozole
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Masato TakahashiBreast Surgery, Hokkaido University Hospital, Sapporo, Hokkaido, Japan. masato.takahashi0725@gmail.com.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.
Tomofumi OsakoBreast Center, Kumamoto Shinto General Hospital, Kumamoto, Japan.
Kenichi InoueDepartment of Breast Care, Saitama Medical Center, Saitama, Japan.
Masahiro KawashimaDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hideki MaedaDepartment of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan.
Mitsuya ItoBreast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Yasuaki SagaraBreast Surgery, Sagara Hospital, Kagoshima, Japan.
Kan YonemoriMedical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Masaya HattoriAichi Breast Clinic Hirabari, Nagoya, Japan.
Naohito YamamotoDivision of Breast Surgery, Chiba Cancer Center, Chiba, Japan.
Yasuaki MuramatsuOncology Medical Affairs , Pfizer Japan Inc, Tokyo, Japan.
Akiko MatsuiOncology Medical Affairs , Pfizer Japan Inc, Tokyo, Japan.
Norikazu MasudaDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn open-label, single-arm, multicenter Japanese phase 2 study (J-Ph2) found first-line palbociclib plus letrozole to be effective and tolerable in postmenopausal Japanese women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (ABC), but overall survival (OS) data were immature. Here, we report the final analysis of a follow-up study of J-Ph2 evaluating OS and subsequent therapy.

methodsPatients (N = 42) who participated in J-Ph2 were included in this follow-up study. Primary endpoint was OS; other endpoints included chemotherapy-free survival (CFS) and type and duration of subsequent therapy. Median OS, CFS, and duration of subsequent therapy were estimated using the Kaplan-Meier method; outcomes were stratified by baseline demographic, disease characteristics, and type of second-line therapies.

resultsAt median follow up of 101.0 months, median OS was 85.4 months (95% CI, 64.3-not estimable) and median CFS was 69.1 months (95% CI, 24.2-85.4). Eighty-one percent of patients (34/42) received a second-line therapy; of those, 85.3% (29/34) received endocrine-based therapy and 8.8% (3/34) received chemotherapy. Median duration of second-line therapy was 7.6 months. Sixty-nine percent of patients (29/42) received a third-line therapy; of those, 58.6% (17/29) received endocrine-based therapy and 31.0% (9/29) received chemotherapy; median duration of third-line therapy was 6.0 months.

conclusionThis analysis showed a median OS of  > 7 years with first-line palbociclib plus letrozole in Japanese patients with ER+/HER2- ABC. Patient demographics, disease characteristics, and subsequent therapy decisions may have contributed to the extended median OS observed in this study. CLINICAL

trial registrationClinicalTrials.gov, NCT04735367.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsAdultAgedAged, 80 and overEast Asian PeopleErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansJapanLetrozoleMiddle AgedPiperazinesPostmenopausePyridinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozolepalbociclibPiperazinesPyridinesReceptors, EstrogenBreast cancerJapanOverall survivalPalbociclibSubsequent therapies

Identifiers

PMID40841781
PMCPMC12552339

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.