Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies

Обзор

For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later. A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working. Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.

Вмешательства

• Другое There are no interventions in this observational study.
  There are no interventions in this observational study.

Первичные конечные точки

• Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up [Срок оценки: 5 years]

Вторичные конечные точки (4)

• Distant disease free survival rates stratified by MRD status during neoadjuvant treatment [Срок оценки: 5 years]
• Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up [Срок оценки: 5 years]
• Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark [Срок оценки: 5 years]
• Time from First Positive MRD Sample to Recurrence [Срок оценки: 5 years]

Критерии участия

Критерии включения

All Cohorts:

• Willing and able to participate in the research and provide biospecimens
• Willing and able to provide informed consent
• Must be diagnosed with breast cancer

Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-

• A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
• Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.

Cohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.

Cohort 1C: Triple Negative Breast Cancer

1\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).

Cohort 2: Adjuvant Therapy / Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-

• A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
• Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.
• Have undergone curative intent surgery with no clinical evidence of disease.

Cohort 2B: HER2+

• A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)
• Have undergone curative intent surgery with no clinical evidence of disease.

Cohort 2C: Triple Negative Breast Cancer

• A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)
• Have undergone curative intent surgery with no clinical evidence of disease.

Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)

• A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).
• No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.
• Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.

Критерии исключения

• Not willing or able to adhere with the study procedures
• Active secondary malignancy
• Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 14 центров

• Birmingham Hematology Associates — Birmingham
• PIH Health Whittier Hospital — Whittier
• Cleveland Clinic Florida — Weston
• Southern Illinois Hospital Services — Carbondale
• Cancer Care Specialist of Illinois — O'Fallon
• Goshen Center for Cancer Care — Goshen
• Trinity Health — Ann Arbor
• Oncology Hematology Associates — Springfield
• … и ещё 6 центров

Идентификаторы

NCT: NCT07211178 · TP-CA-010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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