Evidence map›Paper›PMID 39926095›Full record

Trial reportJMA journal2025

Design Paper: A Prospective, Multicenter, Single-arm, Phase II Trial of Tailored Axillary Surgery in Patients with Clinically Node-positive Breast Cancer in the Upfront Surgery Setting.

Yasuaki Sagara, Kaori Terata, Takehiko Sakai, Shin Takayama, Dai Kitagawa, Tsuguo Iwatani, Takahiro Tsukioki, Mami Ogita, Naoko Sanuki, Masayuki Yoshida and 4 more

Abstract readClinical Trial
In one paragraph

Trial report in JMA journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

14 authors.

Yasuaki SagaraDepartment of Breast Surgical Oncology, Social Medical Corporation Hakuaikai Sagara Hospital, Kagoshima, Japan.
Kaori TerataDepartment of Breast and Endocrine Surgery, Akita University Hospital, Akita, Japan.
Takehiko SakaiDepartment of Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of JFCR, Tokyo, Japan.
Shin TakayamaDepartment of Breast Surgery, National Cancer Center Hospital, Tokyo, Japan.
Dai KitagawaDepartment of Breast Surgical Oncology, National Center for Global Health and Medicine, Tokyo, Japan.
Tsuguo IwataniDepartment of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.
Takahiro TsukiokiDepartment of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.
Mami OgitaDepartment of Radiology, The University of Tokyo Hospital, Tokyo, Japan.
Naoko SanukiDepartment of Radiology, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
Masayuki YoshidaDepartment of Diagnostic Pathology, National Cancer Center Hospital, Tokyo, Japan.
Hitoshi TsudaDepartment of Basic Pathology, National Defense Medical College, Japan.
Seiichiro YamamotoShizuoka Graduate University of Public Health, Shizuoka, Japan.
Hiroji IwataDepartment of Advanced Clinical Research and Development, Nagoya City University, Nagoya, Japan.
Tadahiko ShienDepartment of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: This prospective, multicenter, single-arm Phase II trial investigates the feasibility and the safety of tailored axillary surgery (TAS) in patients with clinically node-positive breast cancer who are undergoing upfront surgery. The trial aims to establish the criteria for safely omitting axillary lymph node dissection (ALND) in these cases, potentially shifting breast cancer management by minimizing surgical complications and preserving the patients' quality of life (QOL). Methods: The study includes patients who were diagnosed with invasive breast cancer, particularly those with limited metastatic lymph nodes. The primary objective of this work is to determine the specific combination of clinical and pathological factors that would result in a non-TAS lymph node metastasis proportion of less than 10%. The secondary objectives include assessing the identification rate of the metastatic lymph nodes, the incidence of upper limb lymphedema, and the QOL measures. Results: The results will identify the patient eligibility criteria for the Phase III TAS trial, potentially allowing the omission of ALND in selected patients. This may lead to reduced surgical complications and better preservation of the QOL of patients with breast cancer. Conclusions: The trial's outcome will contribute to the development of the criteria for safely omitting ALND in certain patients with clinically node-positive breast cancer. This approach aims to enhance breast cancer management by reducing surgical burden and improving the patient outcomes.jRCTs: 061220113.

Indexed as

breast cancerlymph node dissectionquality of lifesurgical complicationstailored axillary surgery

Identifiers

PMID39926095
PMCPMC11799411

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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.