Clinical trial · Interventional
Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer
Minimally Invasive Biopsy Technique Predicting Breast Pathological Complete Respons After Neoadjuvant Chemotherapy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| core needle biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- core needle biopsy
- description
- All patients enrolled in this study received a ultrasound-guided multipoint core needle biopsy after surgery.
- interventionNames
- Device: core needle biopsy
Primary outcomes (1)
- measure
- false negative CNB results，reported as the false negative rate (= FNR)
- timeFrame
- after breast surgery, up to 2 weeks after CNB
- description
- non-detected residual tumor by CNB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by CNB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in CNB.
Secondary outcomes (1)
- measure
- negative predictive value (NPV)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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