Evidence map›Paper›PMID 31953696›Full record

ArticleBreast cancer research and treatment2020

A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer.

Norikazu Masuda, Shoichiro Ohtani, Toshimi Takano, Kenichi Inoue, Eiji Suzuki, Rikiya Nakamura, Hiroko Bando, Yoshinori Ito, Kazushige Ishida, Takashi Yamanaka and 9 more

Open access · hybridAbstract read
In one paragraph

Article in Breast cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 7% of its field
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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Breast cancer research : BCR · 2025
    Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. 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
  11. Article
  12. Review
  13. Article
  14. Antibody-drug conjugates come of age in oncology.Nature reviews. Drug discovery · 2023
    Review
  15. Neoadjuvant therapy withAnnals of translational medicine · 2023
    Article
  16. Review
  17. Article
  18. Review
  19. Differences between Japan and China in perioperative pharmacotherapy of early-stage breast cancer in breast cancer guidelines (2022 edition).Translational breast cancer research : a journal focusing on translational research in breast cancer · 2022
    Article
  20. 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

19 authors at 12 institutions in 1 country.

Norikazu MasudaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.ORCID http://orcid.org/0000-0002-7302-0278
Shoichiro OhtaniDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Toshimi TakanoDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.
Kenichi InoueDivision of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
Eiji SuzukiDepartment of Breast Surgery, Kyoto University Hospital, Kyoto, Japan.
Rikiya NakamuraDivision of Breast Surgery, Chiba Cancer Center, Chiba, Japan.
Hiroko BandoBreast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Yoshinori ItoBreast Medical Oncology Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Kazushige IshidaDepartment of Surgery, Iwate Medical University, Morioka, Japan.
Takashi YamanakaDepartment of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Katsumasa KuroiDepartment of Breast Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital, Tokyo, Japan.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Hiroi KasaiInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Tsuyoshi TakasukaOncology Lifecycle Management Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Takaki SakuraiDepartment of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.
Tatsuki R KataokaDepartment of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shinji OhnoBreast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Masakazu ToiBreast Cancer Unit, Kyoto University Hospital, Kyoto University, 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan. toi@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0003-1488-9958
Kyoto University Hospital · JPJapanese Foundation For Cancer Research · JPOsaka National Hospital · JPChiba Cancer Center · JPEbara Hospital · JPHiroshima City Asa Citizens Hospital · JPIwate Medical University · JPKanagawa Prefectural Hospital Organization · JPKyoto University · JPSaitama Cancer Center · JPToranomon Hospital · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe standard of care in the neoadjuvant setting for human epidermal growth factor receptor 2 (HER2)-positive breast cancer is dual HER2-targeted therapy. However, a need to minimize treatment-related toxicity and improve pathological complete response (pCR) rates, particularly in luminal HER2-positive disease, exists.

methodsNeopeaks, a randomized, phase 2 study, compared docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP; 6 cycles; group A), TCbHP (4 cycles) followed by trastuzumab emtansine + pertuzumab (T-DM1+P; 4 cycles; group B), and T-DM1+P (4 cycles; group C) regimens in HER2-positive primary breast cancer patients; concurrent hormone therapy with T-DM1+P was administered in case of estrogen receptor positivity (ER+). Based on tumor shrinkage, nonresponders in group C were switched to 5-fluorouracil + epirubicin + cyclophosphamide (FEC; 4 cycles). Primary endpoint was pCR (comprehensive pCR ypN0 [ypT0-TisypN0]).

resultsOf 236 patients enrolled, 204 were randomized to groups A (n = 51), B (n = 52), and C (n = 101). In group C, 80 (79%) patients continued T-DM1+P following favorable response, whereas 21 (21%) nonresponders switched to FEC. pCR rate was numerically higher with the TCbHP →  T-DM1+P regimen (71%) versus the standard TCbHP (57%) and T-DM1+P (57%) regimens. The rate in group C was higher among responders continuing T-DM1+P (63%) versus nonresponders who switched to FEC (38%). pCR rates after initial 4 cycles of T-DM1+P (group C; 57%) and standard TCbHP regimen (57%) were equivalent. pCR rate in patients with ER+ was significantly higher in group B (69%) than groups A (43%) and C (51%), but was comparable in patients with ER- (67-76%). Compared with the T-DM1-based arm, the incidence of adverse events was higher in the taxane-based arms.

conclusionIn the neoadjuvant setting, the pCR rate with the standard TCbHP →  T-DM1+P regimen was numerically better than the TCbHP regimen alone and significantly better in patients with ER+. Personalization of the T-DM1+P regimen could serve as a reasonable approach to minimize toxicity while maintaining efficacy. Trial registration ID: UMIN-CTR: UMIN000014649.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCarboplatinCombined Modality TherapyErb-b2 Receptor Tyrosine KinasesFemaleHumansMagnetic Resonance ImagingMaytansineNeoadjuvant TherapyRetreatmentTrastuzumabTreatment OutcomeAntibodies, Monoclonal, HumanizedBiomarkers, TumorCarboplatinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesMaytansinepertuzumabTrastuzumabDual HER2-targeted therapyNeoadjuvant therapyPathological complete responsePertuzumabSafetyTrastuzumab emtansine

Identifiers

PMID31953696
PMCPMC7031180
OpenAlexW3000085197

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.