Percutaneous Biopsy After Neoadjuvant Chemotherapy.

Официальное название

Evaluation of the Accuracy of Vacuum-assisted Percutaneous Biopsy in Predicting Mammary Anatomopathological Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

Обзор

Neoadjuvant chemotherapy is widely used in the treatment of locally advanced breast cancer or in early stages of triple-negative or HER2 overexpressing tumors. Pathological complete response (pCR) to neoadjuvant chemotherapy is associated with better clinical outcomes. However, confirmation of pCR still depends on surgery, which may represent overtreatment for some patients. In this context, image-guided vacuum-assisted percutaneous biopsy (VAB) has been investigated as an alternative to assess tumor response and potentially avoid breast surgery in the future. However, there are no studies evaluating this strategy in brazilian patients, the majority of whom present with locally advanced tumors at diagnosis.

Подробное описание

Neoadjuvant chemotherapy is widely used in the treatment of locally advanced breast cancer or in early stages of triple-negative or HER2 overexpressing tumors. Pathological complete response (pCR) to neoadjuvant chemotherapy is associated with better clinical outcomes. However, confirmation of pCR still depends on surgery, which may represent overtreatment for some patients. In this context, image-guided vacuum-assisted percutaneous biopsy (VAB) has been investigated as an alternative to assess tumor response and potentially avoid breast surgery in the future. However, there are no studies evaluating this strategy in brazilian patients, the majority of whom present with locally advanced tumors at diagnosis.

To evaluate the accuracy of VAB in predicting mammary anatomopathological response in breast cancer patients undergoing neoadjuvant chemotherapy.

This is a cross-sectional study conducted at the Cancer Institute of the State of São Paulo (ICESP). It will include patients with invasive mammary carcinoma cT1-T3, N0-N1, M0, of any immunohistochemical profile, with complete clinical and imaging response or residual lesion ≤ 2 cm after neoadjuvant chemotherapy. VAB will be guided by ultrasound or stereotaxy, with at least six fragments obtained and shaving of the remaining area. The concordance between VAB findings and surgical specimen will be analyzed by sensitivity, specificity, and accuracy.

Вмешательства

• Устройство Pre-Neoadjuvant Chemotherapy Clipping
  Patients with an indication for neoadjuvant chemotherapy will be referred for clipping the lesion diagnosed with breast cancer in order to allow subsequent localization of its topography in cases of good response or complete response to treatment. This procedure will be guided by ultrasound, and a specific material consisting of a cannula containing a clip inside is used. Through ultrasound, the cannula is inserted into the center of the target lesion and the clip is positioned at this topograph
• Процедура Vacuum-Assisted Biopsy (VAB)
  Patients with no residual lesion or residual lesion ≤2 cm on MRI and mammography will undergo vacuum-assisted biopsy (VAB) targeting the primary lesion, using the pre-placed clip as a reference under ultrasound or stereotactic guidance. Initially, 6-12 tissue samples will be obtained (7-10G needle) from the clip region, with specimen radiography performed to confirm clip retrieval; additional sampling will continue if the clip is not identified. This initial sample (AM1) will be formalin-fixed.

Первичные конечные точки

• Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of Vacuum-Assisted Biopsy (VAB) in Detecting Pathological Complete Response (pCR) Compared to Surgical Specimen Histopathology [Срок оценки: From completion of neoadjuvant chemotherapy to definitive breast surgery]

Вторичные конечные точки (1)

• Rate of Complete Residual Lesion Removal by Vacuum-Assisted Biopsy (VAB) Confirmed by Surgical Specimen Histopathology [Срок оценки: From VAB procedure to surgical resection]

Критерии участия

Критерии включения

• Female patients with invasive non-special type mammary carcinoma (any immunohistochemical subtype: luminal, triple-negative, or HER2+)
• Indication for neoadjuvant chemotherapy
• Tumor clipping performed prior to neoadjuvant chemotherapy
• Clinical staging cT1-T3, N0-N1, M0, defined by clinical examination, mammography, breast MRI, chest/abdomen/pelvis CT, and bone scintigraphy
• Complete clinical and imaging response OR residual lesion ≤2 cm in largest diameter on mammography and MRI after neoadjuvant chemotherapy and before surgical treatment

Критерии исключения

• Multicentric tumors (> 2 lesions)
• Current use of anticoagulants
• Extensive calcifications (> 2 cm)
• Pregnant women
• Not undergoing surgical treatment
• Personal history of other malignancies in the last 5 years
• Absence of residual lesion on imaging in cases of clip migration from the tumor bed marking

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бразилия · 1 центр

• Instituto do Câncer do Estado de São Paulo - ICESP — São Paulo

Публикации

• Boman C, Tranchell C, Liu X, Eriksson Bergman L, Toli MA, Bergh J, Foukakis T, Matikas A. Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2025 Mar 12;23(4):e247093. doi: 10.6004/jnccn.2024.7093. PMID 40073831
• Heil J, Pfob A, Sinn HP, Rauch G, Bach P, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Ditsch N, Rody A, Grosse R, van Mackelenbergh M, Reinisch M, Karsten M, Golatta M; RESPONDER Investigators. Diagnosing Pathologic Complete Response in the Breast After Neoadjuvant Systemic Treatment of Breast PMID 32657944
• Pinder SE, Shaaban A, Deb R, Desai A, Gandhi A, Lee AHS, Pain S, Wilkinson L, Sharma N. NHS Breast Screening multidisciplinary working group guidelines for the diagnosis and management of breast lesions of uncertain malignant potential on core biopsy (B3 lesions). Clin Radiol. 2018 Aug;73(8):682-692. doi: 10.1016/j.crad.2018.04.004. PMID 29773220
• Modestino F, Cappelli A, Mosconi C, Peta G, Bruno A, Vara G, De Benedictis C, Golfieri R. Balloon-assisted coil embolization (BACE) of a wide-necked aneurysm of the inferior pancreaticoduodenal artery. CVIR Endovasc. 2020 Sep 5;3(1):62. doi: 10.1186/s42155-020-00155-w. PMID 32889684
• Jin J. Counseling on Healthy Diet and Physical Activity to Prevent Cardiovascular Disease. JAMA. 2020 Nov 24;324(20):2114. doi: 10.1001/jama.2020.22344. No abstract available. PMID 33231666
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• Alsina Maqueda M, Teijo Quintans A, Cuatrecasas M, Fernandez Acenero MJ, Fernandez Montes A, Gomez Martin C, Jimenez Fonseca P, Martinez Ciarpaglini C, Rivera Herrero F, Iglesias Coma M. Biomarkers in gastroesophageal cancer 2025: an updated consensus statement by the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathology (SEAP). Clin Transl Oncol. 2025 Sep;27(9):3580-3594 PMID 40072752
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Идентификаторы

NCT: NCT07644455 · 5405/25 · 94924026.0.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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