Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy

Официальное название

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

Обзор

This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease

Вмешательства

• Процедура Biospecimen Collection
  Undergo blood sample collection
• Другое Surveys
  Patients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire.
• Лучевая терапия Stereotactic Body Radiation Therapy (SBRT)
  Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
• Процедура Computed Tomography
  Undergo CT, MRI and/or PET/CT
• Процедура Magnetic Resonance Imaging
  Undergo CT, MRI and/or PET/CT
• Процедура Positron Emission Tomography
  Undergo CT, MRI and/or PET/CT

Первичные конечные точки

• Freedom from a change in systemic therapy (FCST) - overall [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A) [Срок оценки: 6 months]
• Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B) [Срок оценки: 6 months]
• Progression-free survival (PFS) [Срок оценки: Up to 5 years]
• Overall survival (OS) [Срок оценки: Up to 5 years]
• Quality of life - EQ-5D-5L [Срок оценки: Up to 5 years]
• Determine the local control of irradiated, oligoprogressive lesions [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Histological confirmation of primary breast cancer.
• Patients with metastatic breast cancer and at least 12 months of clinical response to first-line systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease, and who plan for the continuation of the current systemic therapy.

• NOTE: patients with de novo metastatic disease and those developed metastatic disease after initially localized disease can both be included.

OR

• Patients with metastatic breast cancer and at least 6 months of clinical response to second-line systemic therapy (or further, e.g., third- or fourth-line), with the subsequent development of 1-3 extracranial sites of oligoprogressive disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
• Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Provide written informed consent.
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
• Willing to provide blood samples for correlative research purposes.
• Receiving radiation therapy as specified in the protocol.

Критерии исключения

• Male patients.
• Nursing or pregnant women.
• Men or women of childbearing potential who are unwilling to employ adequate contraception.
• Patients with triple negative disease (negative for ER, PR, and HER2).
• Active second primary malignancy
• More than 3 extracranial sites of oligoprogressive disease
• Active CNS disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.

• Active connective tissue disease that is felt by the treatment team to pose an excess risk of toxicity.
• Prior radiation that overlaps with the intended treatment volume such that, in the opinion of the patient's Radiation Oncologist, radiotherapy to progressing sites will not be safe.

• NOTE: patients with some dose overlap with prior radiotherapy that is deemed safe by the patient's Radiation Oncologist can be included in the trial.

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

Лечение

Центры проведения

США · 2 центра

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06055881 · GMROR2232 · NCI-2023-03208 · 22-002943 · GMROR2232

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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