Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)

NCT05505357 | Recruiting DMC

• 1 other identifier: KBCSG-24
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.

Conditions

Breast Cancer Invasive

Keywords

neoadjuvant systemic therapy; pathological complete response; vacuum-assisted bIopsy; omission of breast surgery

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.

  5 years after axillary surgery or VAB (in case of axillary surgery omission)

Secondary Outcomes (5)

• Ipsilateral Breast Tumor Recurrence-Free Survival Ipsilateral Breast Tumor Recurrence-Free Survival

  5 years after axillary surgery or VAB (in case of axillary surgery omission)

• Overall Survival

  5 years after axillary surgery or VAB (in case of axillary surgery omission)

• Invasive Disease-Free Survival Invasive Disease-Free Survival

  5 years after axillary surgery or VAB (in case of axillary surgery omission)

• QoL, symptoms, and medical cost

  1 year after axillary surgery or VAB (in case of axillary surgery omission)

• Rate of residual axillary lymph node metastasis on axillary surgery

  Upon axillary surgery

Study Arms (1)

Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy

EXPERIMENTAL

When there is no residual tumor cells on the vacuum-assisted biopsy specimen, breast surgery will be omitted. In the case of clinical N0 AND MRI size ≤ 0.5cm AND lesion-to-background signal enhancement ratio ≤1.6, sentinel lymph node biopsy will be omitted. Otherwise, sentinel lymph node biopsy will be performed. If necessary, axillary lymph node dissection will be performed.

Procedure: Breast surgery omission

Interventions

Breast surgery omission PROCEDURE

For patients who are expected to achieve pathologic complete response after neoadjuvant chemotherapy based on MRI findings, vacuum-assisted biopsy will be performed on the main primary lesion marked with a clip. In case of pCR on vacuum-assisted biopsy specimen, breast surgery will be omitted.

Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: female
• Age: 20 years and older
• Patients with no clinical/radiologic distant metastasis
• Tumor type: Invasive ductal carcinoma
• Tumor subtype: HER2 positive(including luminal B type, triple negative
• Extent of disease: initial tumor size ≤ 5cm, cN0-2
• Patients with measurable tumor size
• Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6)
• Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy
• Patients with informed consent who are competent to make a voluntary decision

You may not qualify if:

• Multifocal lesion (≥2)
• Extent of residual microcalcification after neoadjuvant chemotherapy \> 2cm
• Bilateral breast cancer or inflammatory breast cancer
• Contraindication to radiotherapy
• History of previous contralateral breast cancer
• Breast cancer patients with distant metastasis
• Allergic history to MRI contrast
• Male breast cancer
• Patients incapable of giving informed consent owing to poor general conditions
• Patients with BRCA mutation
• Patients willing to receive breast surgery
• Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (4)

• Kim SY, Cho N, Shin SU, Lee HB, Han W, Park IA, Kwon BR, Kim SY, Lee SH, Chang JM, Moon WK. Contrast-enhanced MRI after neoadjuvant chemotherapy of breast cancer: lesion-to-background parenchymal signal enhancement ratio for discriminating pathological complete response from minimal residual tumour. Eur Radiol. 2018 Jul;28(7):2986-2995. doi: 10.1007/s00330-017-5251-8. Epub 2018 Jan 29.

  PMID: 29380033 BACKGROUND

• Lee HB, Han W, Kim SY, Cho N, Kim KE, Park JH, Ju YW, Lee ES, Lim SJ, Kim JH, Ryu HS, Lee DW, Kim M, Kim TY, Lee KH, Shin SU, Lee SH, Chang JM, Moon HG, Im SA, Moon WK, Park IA, Noh DY. Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial. Breast Cancer Res Treat. 2020 Jul;182(1):97-105. doi: 10.1007/s10549-020-05678-3. Epub 2020 May 16.

  PMID: 32418044 BACKGROUND

• Tasoulis MK, Lee HB, Yang W, Pope R, Krishnamurthy S, Kim SY, Cho N, Teoh V, Rauch GM, Smith BD, Valero V, Mohammed K, Han W, MacNeill F, Kuerer HM. Accuracy of Post-Neoadjuvant Chemotherapy Image-Guided Breast Biopsy to Predict Residual Cancer. JAMA Surg. 2020 Dec 1;155(12):e204103. doi: 10.1001/jamasurg.2020.4103. Epub 2020 Dec 16.

  PMID: 33026457 BACKGROUND

• Jung JJ, Cheun JH, Kim SY, Koh J, Ryu JM, Yoo TK, Shin HC, Ahn SG, Park S, Lim W, Nam SE, Park MH, Kim KS, Kang T, Lee J, Youn HJ, Kim YS, Yoon CI, Kim HK, Moon HG, Han W, Cho N, Kim MK, Lee HB. Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial. J Breast Cancer. 2024 Feb;27(1):61-71. doi: 10.4048/jbc.2023.0265.

  PMID: 38433091 DERIVED

Study Officials

• Han-Byoel Lee

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han-Byoel Lee

CONTACT

+82-2-2072-3447; hblee80@gmail.com

Hong-Kyu Kim

CONTACT

+82-2-2072-2980; hkkim4592@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: September 22, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2031
• Last Updated: February 28, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: March 2032
• Access Criteria: Upon request

Locations

KR (1)