Breast Cancer InvasiveOPTIMISTNCT05505357
Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
A study testing Breast surgery omission in people with Breast Cancer Invasive, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- Breast surgery omission
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2022to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Han-Byoel Lee, hblee80@gmail.com
Hong-Kyu Kim, hkkim4592@gmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer Invasive
- Being tested
- Breast surgery omission
- Keywords
- neoadjuvant systemic therapy, pathological complete response, vacuum-assisted bIopsy, omission of breast surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast surgery omissionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Breast surgery omission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.
Measured: 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
Proportion of patients with no disease recurrence in the ipsilateral breast or death
Measured: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Overall Survival
Proportion of patients with no death.
Measured: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
Invasive Disease-Free Survival Invasive Disease-Free Survival
Proportion of patients with no invasive disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death.
Measured: 5 years after axillary surgery or VAB (in case of axillary surgery omission)
QoL, symptoms, and medical cost
Analysis of QoL survey (BREAST-Q), procedure-related symptoms, and medical cost
Measured: 1 year after axillary surgery or VAB (in case of axillary surgery omission)
Rate of residual axillary lymph node metastasis on axillary surgery
Proportion of patients with metastatic lymph nodes among those with pCR on VAB
Measured: Upon axillary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start22 Sep 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 533 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor
- Investigators
- Han-Byoel Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505357
- Sponsor's protocol ID
- KBCSG-24
- Acronym
- OPTIMIST
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on Request (hblee80@gmail.com; hblee.md@snu.ac.kr)
Publications
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.
PubMed 29380033Lee 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.
PubMed 32418044Tasoulis 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.
PubMed 33026457Jung 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.
PubMed 38433091
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05505357
- Acronym / sponsor ID
- OPTIMIST / KBCSG-24
- Conditions
- Breast Cancer Invasive
- Keywords
- neoadjuvant systemic therapy, pathological complete response, vacuum-assisted bIopsy, omission of breast surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 533 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy | Experimental | Procedure: Breast surgery omissionWhen 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast surgery omissionFor 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. | Procedure or surgery | Patients with pCR predicted by MRI and vacuum-assisted biopsy (VAB) after neoadjuvant chemotherapy |
Primary outcome
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 secondary outcomes
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)
Overall Survival
Time frame: 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)
QoL, symptoms, and medical cost
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 29380033Kim 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.
- Background: PubMed 32418044Lee 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.
- Background: PubMed 33026457Tasoulis 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.
- Derived from this study: PubMed 38433091Jung 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.
- Individual participant dataSharing planned: Yes. Available on Request (hblee80@gmail.com; hblee.md@snu.ac.kr)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Han-Byoel Lee principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast surgery omission in people with Breast Cancer Invasive, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han-Byoel Lee (+82-2-2072-3447, hblee80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: 5 years after axillary surgery or VAB (in case of axillary surgery omission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505357, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.