Evidence map›Paper›PMID 38767786›Full record

Trial reportBreast cancer research and treatment2024

Long-term outcomes of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) and docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) for HER2-positive primary breast cancer: results of the randomized phase 2 JBCRG20 study (Neo-peaks).

Toshimi Takano, Norikazu Masuda, Mitsuya Ito, Kenichi Inoue, Yuko Tanabe, Kousuke Kawaguchi, Hiroyuki Yasojima, Hiroko Bando, Rikiya Nakamura, Takashi Yamanaka and 10 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Escalation and optimisation of primary breast cancer treatment with antibody-drug conjugates.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025
    Review
  5. Article
  6. Review
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.

Toshimi TakanoDepartment of Breast Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID http://orcid.org/0000-0002-8417-5291
Norikazu MasudaDepartment of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8550, Japan. nmasuda@alpha.ocn.ne.jp.ORCID http://orcid.org/0000-0002-7302-0278
Mitsuya ItoDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Kenichi InoueDivision of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
Yuko TanabeDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0001-9279-5952
Kousuke KawaguchiDepartment of Breast Surgery, Kyoto University Hospital, Kyoto, Japan.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan.
Hiroko BandoBreast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.ORCID http://orcid.org/0000-0002-7361-3647
Rikiya NakamuraDivision of Breast Surgery, Chiba Cancer Center, Chiba, Japan.ORCID http://orcid.org/0000-0002-4349-9046
Takashi YamanakaDepartment of Breast Surgery and Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Kazushige IshidaDepartment of Surgery, Iwate Medical University, Morioka, Japan.ORCID http://orcid.org/0000-0001-7727-8869
Tomoyuki ArugaSurgery (Breast), Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0003-3442-8972
Yasuhiro YanagitaDepartment of Breast Oncology, Gunma Prefectural Cancer Center, Ota, Japan.
Eriko TokunagaDepartment of Breast Oncology, NHO Kyushu Cancer Center, Fukuoka, Japan.
Kenjiro AogiDepartment of Breast Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
Shinji OhnoDepartment of Breast Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Hiroi KasaiClinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.
Tatsuki R KataokaDepartment of Diagnostic Pathology, Iwate Medical University, Morioka, Japan.ORCID http://orcid.org/0000-0003-3095-8976
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Masakazu ToiTokyo Metropolitan Komagome Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe randomized phase 2 Neo-peaks study examined usefulness of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) following docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) as compared with the standard TCbHP regimen. We previously reported that pCR rate after neoadjuvant therapy tended to be higher with TCbHP followed by T-DM1 + P. We conducted an exploratory analysis of prognosis 5 years after surgery.

methodsNeoadjuvant treatment with TCbHP (6 cycles; group A), TCbHP (4 cycles) followed by T-DM1 + P (4 cycles; group B), and T-DM1 + P (4 cycles; group C, + 2 cycles in responders) were compared. Group C non-responders after 4 cycles were switched to an anthracycline-based regimen. We evaluated 5-year disease-free survival (DFS), distant DFS (DDFS), and overall survival (OS).

resultsData from 203 patients (50, 52, and 101 in groups A-C, respectively) were analyzed. No significant intergroup differences were found for DFS, DDFS, or OS. The 5-year DFS rates (95% CI) were 91.8% (79.6-96.8%), 92.3% (80.8-97.0%), and 88.0% (79.9-93.0%) in groups A-C, respectively. TCbHP followed by T-DM1 + P and T-DM1 + P with response-guided addition of anthracycline therapy resulted in similar long-term prognosis to that of TCbHP.

conclusionsIn patients who achieved pCR after neoadjuvant therapy with T-DM1 + P, omission of adjuvant anthracycline may be considered, whereas treatment should be adjusted for non-pCR patients with residual disease. T-DM1 + P with response-guided treatment adjustment may be useful for minimizing toxicity. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: UMIN-CTR, UMIN000014649, prospectively registered July 25, 2014. Some of the study results were presented as a Mini Oral session at the ESMO Breast Cancer 2023 (Berlin, Germany, 11-13 May 2023).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinDocetaxelErb-b2 Receptor Tyrosine KinasesNeoadjuvant TherapyTrastuzumabAdo-Trastuzumab EmtansineAdultAgedFemaleHumansMiddle AgedPrognosisTreatment OutcomeAdo-Trastuzumab EmtansineAntibodies, Monoclonal, HumanizedCarboplatinDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumabDe-escalationLong-term outcomesNeoadjuvant therapyPertuzumabResponse-guided treatmentTrastuzumab emtansine

Identifiers

PMID38767786
PMCPMC11230995

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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.