Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer (MIBPBPCR)

Shandong First Medical University

Status

Unknown

Conditions

Breast Cancer

Treatments

Device: core needle biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT03789851

MIB001

Details and patient eligibility

About

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.

Full description

In clinical routine surgical treatment follows the neoadjuvant chemotherapy (NAC). However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future. However, up to now, prediction of pCR after NACT is only moderately accurate. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge.

From June 1st, 2017 to June 15th, 2019 the investigators performed ultrasound-guided multipoint core needle biopsy (CNB) on 50 breast cancer patients after NAC and directly after surgery. To analyse CNB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

after full-course neoadjuvant chemotherapy (NAC) according to the NACT protocol
with cT1c-cT4a-c tumors
after informed consent
with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
Clinical / imaging partial or complete response to NAC
Any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy)
Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography
Inclusion of only one breast per patient, in bilateral cancer one breast can be included
In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.

Exclusion criteria

Palliative or recurrent breast cancer
Pregnancy and lactation
cT4d stage (inflammatory breast cancer)
M1 stages
stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
dislocation of marker (> 10mm distance to the initial lesion)