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Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer

NCT03789851 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-12-31

No results posted yet for this study

Summary

Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete remission (pCR) can be achieved. With improvements in molecular typing guided NAC and targeted therapies, there has been dramatic improvement in pCR rates, especially among triple-negative and human epidermal growth factor receptor 2 positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher. NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer, and the need for breast surgery in NAC cases with pCR has been questioned, especially in patients undergoing breast-conserving surgery with whole breast radiotherapy. The main impediments for potential elimination of breast surgery have been the fact that conventional and functional breast imaging techniques are incapable of accurate prediction of residual disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the potential to overcome this impediment.

The investigators design and begin a prospective one-armed clinical study to explore the accuracy of MIB in predicting breast pCR after NAC.

Conditions

Interventions

DEVICE

core needle biopsy

Because the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area.

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-06-15
Completion
2020-06-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789851 on ClinicalTrials.gov