Evidence map›Paper›PMID 38433091›Full record

ArticleJournal of breast cancer2024

Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial.

Ji-Jung Jung, Jong-Ho Cheun, Soo-Yeon Kim, Jiwon Koh, Jai Min Ryu, Tae-Kyung Yoo, Hee-Chul Shin, Sung Gwe Ahn, Seho Park, Woosung Lim and 14 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of breast cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05505357 (Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
6.0field-weighted citation impact, top 3% 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.

NCT05505357 narecruitingnot on this map

Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial

TypeinterventionalSponsorSeoul National University HospitalRan2022 to 2031Enrolled533ConditionsBreast Cancer InvasiveArmsBreast surgery omission
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 21 citations in OpenAlex.

  1. De-escalation of breast surgery for early stage breast cancer.Japanese journal of clinical oncology · 2026
    Review
  2. Review
  3. Article
  4. Extent of resection in breast conserving surgery after neoadjuvant chemotherapy: a literature review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Omission of breast surgery in exceptional responders after neoadjuvant chemotherapy-what are future possibilities?-a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025
    Review
  11. Observational
  12. Article
  13. 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

24 authors at 14 institutions in 1 country.

Ji-Jung Jung *Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-4080-1075
Jong-Ho Cheun *Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.ORCID https://orcid.org/0000-0001-9986-5597
Soo-Yeon Kim *Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-8915-3924
Jiwon Koh *Department of Pathology, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-7687-6477
Jai Min RyuDivision of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-5405-7385
Tae-Kyung YooDepartment of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-5790-353X
Hee-Chul ShinDepartment of Surgery, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-6512-2218
Sung Gwe AhnDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-8778-9686
Seho ParkDepartment of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-8089-2755
Woosung LimDepartment of Surgery, College of Medicine, Ewha Womans University, Seoul, Korea.ORCID https://orcid.org/0000-0002-2863-9346
Sang-Eun NamDepartment of Surgery, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-8253-6420
Min Ho ParkDepartment of Surgery, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea.ORCID https://orcid.org/0000-0002-7046-3874
Ku Sang KimDepartment of Breast Surgery, Gospel Hospital, Kosin University College of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0003-2710-112X
Taewoo KangDepartment of Surgery, Pusan National University, School of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0002-6279-0904
Jeeyeon LeeDepartment of Surgery, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.ORCID https://orcid.org/0000-0003-1826-1690
Hyun Jo YounDepartment of Surgery, Jeonbuk National University Medical School, Jeonju, Korea.ORCID https://orcid.org/0000-0002-2407-8537
Yoo Seok KimDepartment of Surgery, Chosun University College of Medicine, Gwangju, Korea.ORCID https://orcid.org/0000-0002-5853-4748
Chang Ik YoonDivision of Breast Surgery, Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID https://orcid.org/0000-0002-7273-8886
Hong-Kyu KimDepartment of Surgery, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-4425-972X
Hyeong-Gon MoonDepartment of Surgery, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-9981-0286
Wonshik HanDepartment of Surgery, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-7310-0764
Nariya ChoDepartment of Radiology, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-4290-2777
Min Kyoon KimDepartment of Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea. likeicetea@hanmail.net.ORCID https://orcid.org/0000-0002-1848-7801
Han-Byoel LeeDepartment of Surgery, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-0152-575X
Seoul National University · KRYonsei University · KRChonnam National University Hwasun Hospital · KRChosun University · KRChung-Ang University Hospital · KREwha Womans University · KRJeonbuk National University · KRKonkuk University Medical Center · KRKosin University Gospel Hospital · KRKyungpook National University Hospital · KRPusan National University Hospital · KRSamsung Medical Center · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRUlsan College · KR

Funding

Ministry of Health and Welfare HA22C0098
6 · The paper itself

Abstract

purposeAdvances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.

methodsThe Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuum-assisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years. DISCUSSION: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.

trial registrationClinicalTrials.gov Identifier: NCT05505357. Registered on August 17, 2022. Clinical Research Information Service Identifier: KCT0007638. Registered on July 25, 2022.

Indexed as

BiopsyBreast NeoplasmsClinical TrialMulticenter StudyNeoadjuvant Therapy

Identifiers

PMID38433091
PMCPMC10912576
OpenAlexW4392017843

What OpenQuestion holds

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Registered trials

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.