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The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.
Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core needle Biopsy | Experimental | Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. |
|
| Vacuum-assisted biopsy | Experimental | Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally-invasive biopsy | Procedure | Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive Value | Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| False Negative Rate | Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR | 2 weeks |
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Inclusion Criteria:
Patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wonshik Han, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33307491 | Derived | Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8. |
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IPD including study protocol, informed consent form, clinical study report and analytic code will be shared.
Starting 6 months after publication.
PI will review requests for IPD.
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All enrolled patients completed the protocol for minimally-invasive biopsy and subsequent wide excision.
Sep 2016 to Feb 2018 at Breast Care Center, Seoul National University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Needle Biopsy | Image-guided core needle biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI. The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively. |
| FG001 | Vacuum-assisted Biopsy | Image-guided vacuum-assisted biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI. The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Core Needle Biopsy | Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. |
| BG001 | Vacuum-assisted Biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Negative Predictive Value | Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR | Number of participants with no tumor on biopsy | Posted | Number | 95% Confidence Interval | percentage of participants | 2 weeks |
|
2 weeks after intervention (CNB or VAB)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Core Needle Biopsy | Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Surgical and medical procedures | Non-systematic Assessment | post-biopsy bleeding |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wonshik Han | Seoul National University Hospital | +82-2-2072-1958 | hanw@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2016 | Mar 27, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2016 | Mar 27, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
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|
| wide excision | Procedure | Surgical wide excision of the biopsied area. |
|
Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Tumor size before neoadjuvant chemotherapy | Maximum tumor size on imaging in mm before neoadjuvant chemotherapy | Mean | Standard Deviation | millimeters |
|
| OG002 | Total | Ultrasound-guided core needle biopsy + vacuum-assisted biopsy |
|
|
| Secondary | False Negative Rate | Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR | Posted | Number | percentage of participants | 2 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Vacuum-assisted Biopsy | Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. | 0 | 20 | 0 | 20 | 2 | 20 |
| hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |