Evidence map›Paper›PMID 40186791›Full record

Observational studyBreast cancer (Tokyo, Japan)2025

Overall survival of palbociclib plus endocrine therapy in Japanese patients with HR+/HER2- advanced breast cancer in the first-or second-line setting: a multicenter observational study (P-BRIDGE study).

Shigenori E Nagai, Masaya Hattori, Tetsuhiro Yoshinami, Hiroko Masuda, Takuho Okamura, Kenichi Watanabe, Takahiro Nakayama, Michiko Tsuneizumi, Daisuke Takabatake, Michiko Harao and 13 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Breast cancer (Tokyo, Japan), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05399329 (Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings), which is not on this 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.

NCT05399329 completednot on this map

Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings

TypeobservationalSponsorPfizerRan2022 to 2025Enrolled693ConditionsBreast CancerArmsPalbociclib, Endocrine therapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Shigenori E NagaiDivision of Breast Oncology, Saitama Prefectural Cancer Center, Saitama, Japan.ORCID http://orcid.org/0000-0003-2887-6066
Masaya HattoriDepartment of Breast Oncology, Aichi Cancer Center, Nagoya, Japan.
Tetsuhiro YoshinamiDepartment of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Hiroko MasudaDepartment of Breast Surgical Oncology, School of Medicine, Showa University, Tokyo, Japan.
Takuho OkamuraDepartment of Breast Oncology, Tokai University School of Medicine, Tokyo, Japan.
Kenichi WatanabeDepartment of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Takahiro NakayamaDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.
Michiko TsuneizumiDepartment of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.
Daisuke TakabatakeDepartment of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Michiko HaraoDepartment of Breast Oncology, Jichi Medical University, Shimotsuke, Japan.
Hiroshi YoshinoBreast and Endocrinological Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
Natsuko MoriDepartment of Breast Surgery, Seirei Hamamatsu General Hospital, Hamamatsu, Japan.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Chiya OshiroDepartment of Breast Surgery, Kaizuka City Hospital, Osaka, Japan.
Madoka IwaseDepartment of Breast and Endocrine Surgery, Nagoya University Hospital, Nagoya, Japan.
Miki YamaguchiDepartment of Breast Surgery, JCHO Kurume General Hospital, Kurume, Japan.
Takafumi SangaiDepartment of Breast and Thyroid Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
Shinsuke SasadaDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.
Takanori IshidaDivision of Breast and Endocrine Surgical Oncology, Tohoku University Graduate School of Medicine, Tokyo, Japan.
Manabu FutamuraDepartment of Breast Surgery, Gifu University Hospital, Gifu, Japan.
Yasuaki MuramatsuOncology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.
Nobuyoshi KosakaOncology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.ORCID http://orcid.org/0000-0001-5571-261X
Norikazu MasudaDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan. nmasuda@alpha.ocn.ne.jp.ORCID http://orcid.org/0000-0002-7302-0278

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecently, we reported the real-world effectiveness of palbociclib plus endocrine therapy (ET) in HR+/HER2- advanced breast cancer (ABC) in Japan (NCT05399329). However, median overall survival (OS) was not reached because of limited follow-up (36 months). Here, we present follow-up data from this study, including real-world clinical outcomes and treatment patterns.

methodsThe P-BRIDGE study was a multi-center, observational study evaluating the real-world effectiveness and treatment patterns of patients diagnosed with HR+/HER2- ABC who received palbociclib plus ET in first (1L) or second line (2L) in Japan. The primary endpoint was real-world progression-free survival (rwPFS); secondary endpoints included OS and chemotherapy-free survival (CFS).

resultsOf the 693 eligible patients, 426 and 267 patients received palbociclib with ET as 1L and 2L treatment, respectively. After a median follow-up of 48.1 months, the median rwPFS (95% CI) was 26.2 months (21.4-30.4) for 1L and 14.9 months (11.7-18.3) for 2L, respectively. Median OS (95% CI) was 68.2 months (60.8-NE) for 1L and 50.7 months (42.2-57.2) for 2L, respectively. OS analysis was also performed in the following subgroups: TFI < 12 months/TFI ≥ 12months/de novo metastatic median OS was 56.3 months (43.9-68.2), NR (NE-NE), NR (56.3-NE), visceral metastasis was 65.0 months (56.3-NE), liver metastasis was 46.4 months (37.2-NE), and bone only metastasis was NR (57.8-NE) in 1L, respectively.

conclusionsThe updated results from this study further confirm the real-world effectiveness of palbociclib plus ET in routine clinical practice in Japan. More than 5 years of median OS in 1L was observed, supporting the use of palbociclib plus ET as 1L standard of care for HR+/HER2- ABC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsPiperazinesPyridinesAdultAgedAged, 80 and overAntineoplastic Agents, HormonalEast Asian PeopleErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansJapanMiddle AgedProgression-Free SurvivalAntineoplastic Agents, HormonalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespalbociclibPiperazinesPyridinesReceptors, EstrogenReceptors, ProgesteroneAdvanced breast cancerCDK4/6 inhibitorsJapanese patientsOverall survivalPalbociclibReal-world evidence

Identifiers

PMID40186791
PMCPMC12174214

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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.