Trial Outcomes & Findings for Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy. (NCT NCT03273426)

NCT ID: NCT03273426

Last Updated: 2020-04-09

Results Overview

Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-04-09

Participant Flow

Sep 2016 to Feb 2018 at Breast Care Center, Seoul National University Hospital

All enrolled patients completed the protocol for minimally-invasive biopsy and subsequent wide excision.

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.

Baseline characteristics by cohort

Measure	Core Needle Biopsy n=20 Participants Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Vacuum-assisted Biopsy n=20 Participants Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 10.74 • n=5 Participants	46.5 years STANDARD_DEVIATION 10.03 • n=7 Participants	49 years STANDARD_DEVIATION 10.29 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment South Korea	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Tumor size before neoadjuvant chemotherapy	29.55 millimeters STANDARD_DEVIATION 15.51 • n=5 Participants	31.8 millimeters STANDARD_DEVIATION 12.90 • n=7 Participants	30.68 millimeters STANDARD_DEVIATION 14.13 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Number of participants with no tumor on biopsy

Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

Outcome measures

Measure	Core Needle Biopsy n=17 Participants Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Vacuum-assisted Biopsy n=14 Participants Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Total n=31 Participants Ultrasound-guided core needle biopsy + vacuum-assisted biopsy
Negative Predictive Value	88.2 percentage of participants Interval 71.94 to 95.64	85.7 percentage of participants Interval 64.37 to 95.22	87.1 percentage of participants Interval 74.92 to 93.85

SECONDARY outcome

Timeframe: 2 weeks

Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

Outcome measures

Measure	Core Needle Biopsy n=20 Participants Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Vacuum-assisted Biopsy n=20 Participants Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Total Ultrasound-guided core needle biopsy + vacuum-assisted biopsy
False Negative Rate	40 percentage of participants	25 percentage of participants	—

Adverse Events

Core Needle Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vacuum-assisted Biopsy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Core Needle Biopsy n=20 participants at risk Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.	Vacuum-assisted Biopsy n=20 participants at risk Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.
Surgical and medical procedures bleeding	0.00% 0/20 • 2 weeks after intervention (CNB or VAB)	5.0% 1/20 • Number of events 1 • 2 weeks after intervention (CNB or VAB)
Surgical and medical procedures hematoma	0.00% 0/20 • 2 weeks after intervention (CNB or VAB)	5.0% 1/20 • Number of events 1 • 2 weeks after intervention (CNB or VAB)

Additional Information

Dr. Wonshik Han

Seoul National University Hospital

Phone: +82-2-2072-1958

Email: hanw@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place