Active — Not RecruitingNot Applicable

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)

United States65 participantsStarted 2022-12-12

Plain-language summary

ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease
✓. ER+/HER2- patients prior to starting 2nd line therapy or beyond OR ER/Progesterone Receptor (PR)/HER2-negative (Triple Negative) patients prior to starting any line of therapy
✓. Measurable and/or non-measurable disease is allowed
✓. Male or female breast cancer is allowed
✓. Age \> 18 years
✓. Willingness to provide mandatory blood specimens
✓. Willing to return to enrolling institution for follow up imaging at least once

✕. Life expectancy of ≤ 6 months
✕. Inability to provide blood samples based on the judgment of the treating provider

To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients

Timeframe: 3 to 4 months

NCT IDNCT05662345

SponsorMenarini Silicon Biosystems, INC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-14