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

February 25, 2024 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

[Background & Rationale for Study]

Optimization (rather than de-escalation) of surgery for breast cancer is essential for our patients, and thus it is an important topic discussed actively in all major conferences regarding breast cancer and oncology.

A previous study showed that lesion-to-background parenchymal signal enhancement ratio (L-to-B SER) ≤1.6 and/or size ≤ 0.2cm on breast MRI can distinguish pathological complete response (pCR) from minimal residual cancer following neoadjuvant systemic therapy (NST). In a separate prospective study, 40 patients with near pCR (either tumor size ≤ 0.5 cm or L-to-B SER ≤ 1.6 on MRI) were enrolled and evaluated for the accuracy of US-guided biopsy aided by MRI in predicting pCR in the breast after NST. US-guided multiple core needle biopsy (CNB) or VAB of the tumor bed, followed by standard surgical excision, was performed. Matched biopsy and surgical specimens were compared to assess pCR. In result, obtaining at least 5 biopsy cores based on tumor size ≤ 0.5 cm and an L-to-B SER of ≤ 1.6 on MRI resulted in 100% NPV and accuracy. No differences in accuracy were noted between CNB and VAB (90% vs. 90%). It was demonstrated that patients who meet these stringent criteria on MRI may forego surgery for breast cancer.

Also, a pooled analysis of data from The Royal Marsden, MD Anderson Cancer Center, and Seoul National University Hospital showed that a VAB obtaining at least 6 cores for a lesion ≤2cm on imaging after NST can accurately predict pCR at a FNR of 3.2%.

For patients who would not benefit from surgery, it is unnecessary in terms of both personal and national medical expenses. Therefore, in order to establish the rationale for whether surgery could be omitted for patients with predicted pCR, it is necessary to demonstrate that the survival rate of patients who skipped breast surgery after confirming no residual cancer on VAB is non-inferior than that of patients who underwent breast surgery.

[Study Objectives]

To show non-inferiority in terms of disease-free survival (DFS) of omission of breast surgery for breast cancer patients who show no residual tumor on VAB after NST.

[Study design]

Prospective, multicenter, single-arm, non-inferiority trial

Study Type

Interventional

Enrollment (Estimated)

533

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ipsilateral Breast Tumor Recurrence-Free Survival Ipsilateral Breast Tumor Recurrence-Free Survival
Time Frame: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Proportion of patients with no disease recurrence in the ipsilateral breast or death
5 years after axillary surgery or VAB (in case of axillary surgery omission)
Overall Survival
Time Frame: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Proportion of patients with no death.
5 years after axillary surgery or VAB (in case of axillary surgery omission)
Invasive Disease-Free Survival Invasive Disease-Free Survival
Time Frame: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Proportion of patients with no invasive 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)
QoL, symptoms, and medical cost
Time Frame: 1 year after axillary surgery or VAB (in case of axillary surgery omission)
Analysis of QoL survey (BREAST-Q), procedure-related 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
Time Frame: Upon axillary surgery
Proportion of patients with metastatic lymph nodes among those with pCR on VAB
Upon axillary surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: Han-Byoel Lee, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available on Request (hblee80@gmail.com; hblee.md@snu.ac.kr)

IPD Sharing Time Frame

March 2032

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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