Breast Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMinimally-invasive biopsy
Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.
PROCEDUREwide excision
Surgical wide excision of the biopsied area.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients * with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC) * who received NAC * with detectable lesion / clip marker on ultrasound * with cT1-T3 tumors * clinical and imaging complete or near-complete response on MRI * with informed consent
Exclusion criteria
* Multifocal cancer * Residual microcalcification * Contralateral breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value | 2 weeks | Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| False Negative Rate | 2 weeks | Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR |
Countries
South Korea
Participant flow
Recruitment details
Sep 2016 to Feb 2018 at Breast Care Center, Seoul National University Hospital
Pre-assignment details
All enrolled patients completed the protocol for minimally-invasive biopsy and subsequent wide excision.
Participants by arm
| Arm | Count |
|---|---|
| Core Needle Biopsy Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. | 20 |
| Vacuum-assisted Biopsy Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Vacuum-assisted Biopsy | Core Needle Biopsy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Continuous | 46.5 years STANDARD_DEVIATION 10.03 | 52 years STANDARD_DEVIATION 10.74 | 49 years STANDARD_DEVIATION 10.29 |
| Race/Ethnicity, Customized Asian | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment South Korea | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tumor size before neoadjuvant chemotherapy | 31.8 millimeters STANDARD_DEVIATION 12.9 | 29.55 millimeters STANDARD_DEVIATION 15.51 | 30.68 millimeters STANDARD_DEVIATION 14.13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Negative Predictive Value
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Time frame: 2 weeks
Population: Number of participants with no tumor on biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Needle Biopsy | Negative Predictive Value | 88.2 percentage of participants |
| Vacuum-assisted Biopsy | Negative Predictive Value | 85.7 percentage of participants |
| Total | Negative Predictive Value | 87.1 percentage of participants |
Secondary
False Negative Rate
Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Needle Biopsy | False Negative Rate | 40 percentage of participants |
| Vacuum-assisted Biopsy | False Negative Rate | 25 percentage of participants |