Evidence map›Paper›PMID 41572060›Full record

ArticleInternational journal of clinical oncology2026

Clinical complete response and predictive factors in HER2-positive early breast cancer treated with neoadjuvant chemotherapy aimed at omission of surgery: an exploratory analysis of the JCOG1806 trial.

Hideo Shigematsu, Tomomi Fujisawa, Fumikata Hara, Hiroji Iwata, Toshiyuki Ishiba, Yukinori Ozaki, Takehiko Sakai, Yasuaki Sagara, Akihiko Shimomura, Kazuki Sudo and 8 more

Abstract read
In one paragraph

Article in International journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. De-escalation of breast surgery for early stage breast cancer.Japanese journal of clinical oncology · 2026
    Review
  2. Article
  3. Observational
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

18 authors.

Hideo ShigematsuDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University Hospital, 1-2-3-Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan. shigematu1330@yahoo.co.jp.ORCID http://orcid.org/0000-0001-9393-9655
Tomomi FujisawaGunma Prefectural Cancer Center, Gunma, Japan.
Fumikata HaraAichi Cancer Center, Aichi, Japan.
Hiroji IwataGraduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
Toshiyuki IshibaInstitute of Science Tokyo Hospital, Tokyo, Japan.
Yukinori OzakiCancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Takehiko SakaiCancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Yasuaki SagaraHakuaikai Sagara Hospital, Kagoshima, Japan.
Akihiko ShimomuraNational Center for Global Health and Medicine, Tokyo, Japan.
Kazuki SudoNational Cancer Center Hospital, Tokyo, Japan.
Kaori TerataAkita University Hospital, Akita, Japan.
Yoichi NaitoNational Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Kazuki NozawaGraduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
Keita SasakiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Noriko MitomeJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Ryo SadachiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Taro ShibataJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Tadahiko ShienOkayama University Hospital, Okayama, Japan.

Funding

japan agency for medical research and development (AMED) JP23ck0106846h0001National Cancer Center 29-A-3 2020-J-3 2023-J-03
6 · The paper itself

Abstract

purposeThe JCOG1806 trial (jRCTs031190129) is underway to evaluate the omission of surgery in patients with human epidermal growth factor receptor (HER2)-positive early breast cancer who have a clinical complete response (cCR) after primary systemic therapy (PST). We aimed to assess the cCR rate in this trial and identify predictive factors.

methodsHER2-positivity was defined as an immunohistochemistry (IHC) score of 3 + or in situ hybridization-positivity. A cCR was defined as the absence of detectable lesions upon palpation, contrast-enhanced magnetic resonance imaging, and ultrasonography; biopsy-based confirmation was optional in hormone receptor (HR)-negative cases and mandatory in HR-positive cases. Multivariate logistic regression analyses were used to identify predictors of a cCR.

resultsThe cCR rate was 57.6% (196/340 patients; 95% confidence interval [CI]: 52.2-63.0%). Strongly estrogen-receptor (ER)-positive tumors (≥ 10%) were significantly less likely to have a cCR than ER-negative tumors (odds ratio [OR], 0.41; 95% CI: 0.20-0.81). IHC 3 + tumors had higher cCR rates than IHC 1 + or 2 + tumors (OR, 2.19; 95% CI: 1.01-4.74). Compared with histological grade I tumors, cCR odds were higher in grade II (OR: 2.92; 95% CI: 1.07-7.93) and III (OR: 4.90; 95% CI: 1.76-13.7) tumors. Among patients without a cCR patients undergoing surgery, 22.2% were diagnosed with ypT0 tumors upon analysis of surgical specimens.

conclusionER-negativity, an IHC score of 3 + , and a higher histological grade were independent predictors of a cCR. Identifying these features may improve the feasibility and safety of surgery omission for patients with HER2-positive early breast cancer.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesAdultAgedFemaleHumansMiddle AgedNeoadjuvant TherapyPathologic Complete ResponseReceptors, EstrogenTreatment OutcomeERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenBreast cancercCRHER2Omission of surgeryPrimary systemic therapy

Identifiers

PMID41572060
PMCPMC12932372

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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.