NCT03789851: MIBPBPCR

Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer

Status unknown NA Last updated 31 December 2018

What this trial tests

NA trial testing core needle biopsy in Breast Cancer in 50 participants. Status unknown.

Timeline

1 June 2017

Primary endpoint
15 June 2019

1 June 2020

Quick facts

Lead sponsor	Shandong Cancer Hospital and Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	1 June 2017
Primary completion	15 June 2019
Estimated completion	1 June 2020
Sites	1 location across China

Drugs / interventions tested

• core needle biopsy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Shandong Cancer Hospital and Institute

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Predictive factors of pathologically node-negative disease for HER2 positive and triple-negative breast cancer after neoadjuvant therapy.
   Shi Z, Wang X, Qiu P, Liu Y, et al · · 2021 · cited 7× · PMID 33633973 · DOI 10.21037/gs-20-573
2. Minimally invasive biopsy technique predicting breast pathological complete response after neoadjuvant therapy for breast cancer.
   Shi Z, Qiu P, Wang Y, Liu H. · · 2025 · cited 1× · PMID 40771373 · DOI 10.21037/gs-2025-103