Breast Cancer Clinical Trial
Official title:
Minimally Invasive Biopsy Technique Predicting Breast Pathological Complete Respons After Neoadjuvant Chemotherapy for Breast Cancer
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.
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.
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