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Идёт набор NCT07242118

Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management

Без фазы С лечением Breast Cancer Female

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: SABR.
Кому может быть актуально
Состояния в реестре: Breast Cancer Female. Базовые параметры: от 65 лет · Женщины.
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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Обзор

This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.

Подробное описание

This is a prospective, phase II study of women with localized breast cancer receiving non-operative management with SABR delivered to the primary tumor. Patients will be screened that are age 65 and over with invasive breast cancer. Those eligible for the trial will have ER-positive and HER2-negative disease measuring ≤5 cm with negative clinical lymph nodes. Patients that were previously on primary ET, with either stable or progressive disease, will be eligible for this study if other inclusion criteria are met. Participants will receive SABR targeting the tumor consisting of 5 total treatments. Participants will then follow-up as per protocol with quality-of-life assessments and treatment-related toxicity evaluation.

Вмешательства

  • Лучевая терапия SABR
    Radiation therapy will consist of either IMRT or 3D CRT. The modality chosen will be based on the plan with the preferable dosimetric variables and determined by the treating radiation oncology physician. SABR will be prescribed to a total dose of 35 Gy to the GTV over the course of 5 fractions (7 Gy per fraction), ideally treated every other day (excluding weekends). The CTV will be prescribed 30 Gy over 5 fractions, ideally treated every other day.

Первичные конечные точки

  • 1-month post-SABR Physical Well-Being [Срок оценки: 1 month]
Вторичные конечные точки (4)
  • Patient Reported Outcome [Срок оценки: 12 months]
  • Treatment Perception [Срок оценки: 12 months]
  • Incidence of SABR-Related Adverse Events [Safety and Tolerability] [Срок оценки: 12 months]
  • Estimation of Short-term Survival Outcomes [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Women greater than or equal to age 65 years
  • Diagnosis of invasive carcinoma of breast undergoing non-operative management
  • Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease.
  • Tumor measuring ≤5 cm (cT1-T2) and clinically node negative
  • Diagnostic biopsy ER-positive (greater than or equal to 10% ER by immunohistochemistry staining)
  • Diagnostic biopsy HER2-negative according to ASCO/CAP guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization)
  • Suitable for SABR as deemed by the treating radiation oncologist
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

Критерии исключения

  • Active treatment with systemic chemotherapy for breast cancer. Subjects will need to stop any breast cancer chemotherapy agent before enrollment to be included study.
  • Multicentric tumor.
  • Clinical or imaging evidence of distant metastases.
  • Prior ipsilateral breast or thoracic radiation.
  • Autoimmune conditions with associated radiation risks.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Kansas Medical Center — Kansas City
  • University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT07242118 · IIT-2025-CARMEN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗