Evidence map›Paper›PMID 41708933›Full record

Trial reportAnnals of surgical oncology2026

Radiofrequency Ablation for Early Stage Breast Cancer as a Potential Alternative to Partial Mastectomy: 5-Year Results from the Multiple-Center, Single-Arm, Phase 3 RAFAELO Study (NCCH1409).

Takayuki Kinoshita, Shin Takayama, Tomomi Fujisawa, Kenichi Watanabe, Naohito Yamamoto, Tadahiko Shien, Mitsuya Ito, Mina Takahashi, Manabu Futamura, Tatsuya Onishi and 8 more

Abstract readMulticenter StudyClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. De-escalation of breast surgery for early stage breast cancer.Japanese journal of clinical oncology · 2026
    Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. 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

18 authors.

Takayuki KinoshitaDepartment of Breast Surgery, National Hospital Organization Tokyo Medical Center, Meguro-ku, Tokyo, Japan. takinosh@ncc.go.jp.
Shin TakayamaDepartment of Breast Surgery, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Tomomi FujisawaDepartment of Breast Oncology, Gunma Prefectural Cancer Center, Ota City, Gunma, Japan.
Kenichi WatanabeDepartment of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Shiroishi-ku, Sapporo, Hokkaido, Japan.
Naohito YamamotoDepartment of Breast Surgery, Chiba Cancer Center, Chuo-ku, Chiba, Japan.
Tadahiko ShienDepartment of Breast and Endocrine Surgery, Okayama University Hospital, Kita-ku, Okayama-shi, Okayama, Japan.
Mitsuya ItoDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Naka-ku, Hiroshima-shi, Hiroshima, Japan.
Mina TakahashiDepartment of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan.
Manabu FutamuraDepartment of Breast Surgery, Gifu University Hospital, Gifu City, Gifu, Japan.
Tatsuya OnishiDepartment of Breast Surgery, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan.
Masayuki YoshidaDepartment of Diagnostic Pathology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Masato TakahashiDepartment of Breast Surgery, Hokkaido University Hospital, Kita-ku, Sapporo, Hokkaido, Japan.
Hiroyoshi DoiharaDepartment of Surgery, Kawasaki Medical School General Medical Center, Kita-ku, Okayama-shi, Okayama, Japan.
Eiko YorikaneClinical Research Support Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Keiko OhataClinical Research Support Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Ryunosuke MachidaClinical Research Support Office, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Hitoshi TsudaDepartment of Diagnostic Pathology, National Defense Medical College, Tokorozawa, Japan.
RAFAELO Study Group

Funding

Japan Agency for Medical Research and Development (AMED) JP16lk0201029Japan Agency for Medical Research and Development (AMED) JP19ck0106318Japan Agency for Medical Research and Development (AMED) JP23ck0106590
6 · The paper itself

Abstract

backgroundAt present, no clinical guidelines have been established regarding the use of radiofrequency ablation (RFA) for early stage breast cancer. The Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (RAFAELO) study aimed to assess the efficacy and safety of RFA as an alternative to partial mastectomy in patients with early stage breast cancer. PATIENTS AND

methodsThis study was a multicenter, single-arm, phase 3 study. Female patients with a single breast cancer classified as Tis-T1 (tumor size ≤ 1.5 cm), N0M0 Stage 0-I underwent treatment RFA. All patients then received radiation therapy totaling 45-60 Gy. The primary endpoint was the 5-year ipsilateral breast tumor recurrence-free survival (IBTRFS) rate. The threshold for a clinically unacceptable 5-year IBTRFS rate was set at 90% with a one-sided alpha of 5%.

resultsA total of 370 patients underwent RFA and 353 patients (median [IQR] age, 55 [47-65] years) completed the 5-year follow-up. For the primary endpoint, the IBTRFS rate at 5 years was 98.6% (90% CI 97.1-99.3%, 95% CI 96.6-99.4%). The lower limit of the 90% CI was greater than the threshold of 90%, suggesting the noninferiority of RFA to historical control partial mastectomy. During the study, two recurrences were observed in the ipsilateral breast. Skin ulceration grade ≥ 3 was observed in just one of the 370 patients.

conclusionsRFA was shown to be a safe and minimally invasive treatment for early stage breast cancer, comparable in efficacy to partial mastectomy.

Indexed as

Breast NeoplasmsMastectomy, SegmentalNeoplasm Recurrence, LocalRadiofrequency AblationAgedFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm StagingPrognosisSurvival Rate5-year ipsilateral breast tumor recurrence-free survivalEarly stage breast cancerPartial mastectomyRadiofrequency ablationRAFAELO study

Identifiers

PMID41708933

What OpenQuestion holds

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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.