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

Overview

About this study

Collection of blood to track serial circulating tumor cells (CTCs) in subjects with metastatic breast cancer (MBC). Study will also collect data from investigators are Mayo Clinic and the Mayo Clinic Health Systems to determine effectiveness of the proposed process.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease 2 ER+/HER2- patients prior to starting 2nd line therapy or beyond in the metastatic setting OR ER/PR/HER2-negative (Triple Negative) patients prior to starting any line of therapy in the metastatic setting.
  • Note: ER/PR/HER2 status is defined per the 2018 ASCO/CAP guidelines as follows: ER-positive and PR-positive is defined as ≥ 1% reactive cells by immunohistochemical staining. HER2 Negative Disease is defined by meeting one of the following criteria:
    • 0 or 1+ by IHC and not amplified by ISH;
    • 0 or 1+ by IHC and ISH not done;
    • 2+ by IHC and ISH results are:
      • < 6.0 HER2 signals/cell with HER2/CEP17 ratio < 2.0;
    • IHC not done and not amplified by ISH.
  • 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.

Exclusion Criteria:

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

Eligibility last updated 12/20/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Karthik Giridhar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Amrit Singh, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Mina Hanna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions