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Trial Title:
Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
NCT ID:
NCT05505357
Condition:
Breast Cancer Invasive
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
neoadjuvant systemic therapy
pathological complete response
vacuum-assisted bIopsy
omission of breast surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Breast surgery omission
Description:
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.
Arm group label:
Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy
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.
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
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Han-Byoel Lee
Email:
hblee80@gmail.com
Contact backup:
Last name:
Hong-Kyu Kim
Email:
hkkim4592@gmail.com
Start date:
September 22, 2022
Completion date:
June 2031
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Ministry of Health & Welfare, Korea
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05505357