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Идёт набор NCT06067503

Biomarkers to Detect Endocrine Therapy Resistance

Фаза II С лечением Metastatic Cancer Breast Cancer Lobular Breast Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 18F-fluorofuranylnorprogesterone, Liquid Biopsy, Positron Emission Tomography/Computed Tomography.
Кому может быть актуально
Состояния в реестре: Metastatic Cancer, Breast Cancer, Lobular Breast Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Обзор

This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.

Вмешательства

  • Препарат 18F-fluorofuranylnorprogesterone
    The dose of the investigational imaging agent, FFNP, is approximately 7 millicurie (mCi) (259 megabecquerels (MBq)), IV slow infusion over approximately two minutes followed by saline flush.
  • Устройство Liquid Biopsy
    20ml of whole blood will be collected into two Ethylenediaminetetraacetic acid (EDTA) tubes at each timepoint, CTCs are isolated using the microfluidic Versatile Exclusion-based Rare Sample Analysis (VERSA) platform that integrates CTC capture with RNA extraction on a single chip using Exclusion-Based Sample Preparation (ESP) technology
  • Устройство Positron Emission Tomography/Computed Tomography
    FFNP drug in combination with PET/CT scans to image participant

Первичные конечные точки

  • Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy [Срок оценки: baseline, 4 weeks]
  • Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy [Срок оценки: baseline, 4 weeks]
  • Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy [Срок оценки: baseline, 4 weeks]
Вторичные конечные точки (3)
  • Progression Free Survival (PFS) for 6 months [Срок оценки: up to 6 months]
  • Correlation coefficients [Срок оценки: up to 6 months]
  • Adverse Events within 24 hours of FFNP infusion [Срок оценки: a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion]

Критерии участия

Критерии включения

  • Willing to provide informed consent
  • Individuals at least 18 years of age
  • Have biopsy-proven ER/PR-positive (defined as ER ≥1 percent and PR ≥1 percent by IHC) and HER2-negative advanced or metastatic LBC starting new standard of care endocrine therapy
  • Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist
  • Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
  • Willing to comply with all study procedures and be available for the duration of the study
  • Disease may be measurable by RECIST 1.1 criteria or non-measurable. Lesion size must be at least 1cm. If only bone lesions present, they should be lytic or mixed lytic-sclerotic. If only liver lesions present, patient is not eligible.

Критерии исключения

  • Patients with active brain metastases
  • Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination
  • Unable to lie flat during or tolerate PET/CT
  • Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
  • Presence of liver failure as judged by patient's treating physician
  • Individuals who are pregnant, lactating, or planning on becoming pregnant during the study
  • Not suitable for study participation due to other reasons at the discretion of the investigators
  • Patients with progesterone-receptor negative disease defined as PR <1 percent by IHC

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

США · 1 центр
  • UW Carbone Cancer Center — Madison

Идентификаторы

NCT: NCT06067503 · 2023-1103 · Protocol Version 10/2/2023 · SMPH/MEDICINE/HEM-ONC · UW23076

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗