DiviTum Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

Overview

Información sobre este estudio

The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.   

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  •  
  • Females >18 years old.
  • Pre- or post-menopausal HR+ metastatic breast cancer patients who are:
      • Group 1:  scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
        •  
      • Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
      • Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
      • Group 4:  scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA-approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.
      • NOTE:  Patients that meet eligibility criteria for any of the above groups that are already enrolled in an on-going clinical trial are eligible for co-enrollment to this observational study.

Exclusion Criteria: 

  • Treatment including investigational agent or therapies.
  • Early breast cancer diagnosis.
  • Male breast cancer.
  • Currently receiving treatment for other active malignancy at time of registration EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate).
  • Inability to give written informed consent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/19/23. Questions regarding updates should be directed to the study team contact

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Pooja Advani, M.B.B.S., M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20566538

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