Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer

Официальное название

A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)

Обзор

The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard clinical monitoring and therapy. The Investigators have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound (QUS), which is non-invasive, inexpensive and portable.

Подробное описание

This study phase II will demonstrate the use of quantitative ultrasound to guide adaptive chemotherapy for patients with breast cancer. The primary endpoint will be measurement of improved response rate locally. This trial will enroll 240 randomized breast cancer patients to be assess with quantitative ultrasound to guide adaptive neoadjuvant chemotherapy as compared to standard clinical monitoring and therapy. We will evaluate the safety of its use and expect equivalence in this small patient population. This will allow for more accurate estimation of a needed sample size for a phase III superiority trial.

Вмешательства

• Устройство Quantitative ultrasound to guide adaptive chemotherapy
  Quantitative ultrasound results will be used to measure chemotherapy response and guide an adaptive chemotherapy strategy for patients who are found to be nonresponders to their chemotherapy.

Первичные конечные точки

• Measuring the rate of treatment response between the treatment groups [Срок оценки: Up to 5 years]

Вторичные конечные точки (1)

• Clinical efficacy of quantitative ultrasound [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Women ≥ 18 years of age
• Diagnosis of breast cancer with a primary tumour >2cm in size
• With conditions meeting criteria for chemotherapy administration
• Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
• Creatinine ≤175 µmol/L
• Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
• Cardiac function (left ventricular ejection fraction) ≥55%
• Eligible for neoadjuvant chemotherapy.

Критерии исключения

• Inflammatory breast cancer
• Contraindications to neoadjuvant treatment including pregnancy or lactation
• Past medical history of connective tissue disease
• Past history of dermatologic disease involving the breast
• Eastern Cooperative Group Status (ECOG) ≥3
• No peripheral neuropathy of a severity of grade ≥2
• Evidence of distant metastatic disease
• Known sensitivity to components present in ultrasound gel.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Sunnybrook Health Sciences Centre — Toronto

Публикации

• Moore-Palhares D, Alberico D, Chan AW, DiCenzo D, Sannachi L, Dasgupta A, Yip J, Pena MLA, Gandhi S, Pezo R, Eisen A, Jerzak KJ, Gonzalez CAC, Warner E, Wright FC, Look-Hong N, Roberts A, Sadeghi-Naini A, Curpen B, Skarpathiotakis M, Betel C, Kolios MC, Trudeau M, Czarnota GJ. Quantitative ultrasound imaging for predicting response and guiding personalized neoadjuvant chemotherapy in breast cancer PMID 41345775
• Dasgupta A, DiCenzo D, Sannachi L, Gandhi S, Pezo RC, Eisen A, Warner E, Wright FC, Look-Hong N, Sadeghi-Naini A, Curpen B, Kolios MC, Trudeau M, Czarnota GJ. Quantitative ultrasound radiomics guided adaptive neoadjuvant chemotherapy in breast cancer: early results from a randomized feasibility study. Front Oncol. 2024 Apr 19;14:1273437. doi: 10.3389/fonc.2024.1273437. eCollection 2024. PMID 38706611

Идентификаторы

NCT: NCT04050228 · 308-2017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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