- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06388122
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
May 6, 2024 updated by: Mayo Clinic
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic in Florida
-
Contact:
- Clinical Trials
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Pooja Advani, MBBS, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult female patients > 18 years old with diagnosis of metastatic HR positive HER2 negative breast cancer that will be or are currently being treated with standard of care endocrine therapy +/- CDK 4/6 inhibitors.
Description
Inclusion Criteria:
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+ metastatic breast cancer (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 ongoing 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: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
- Inability to give written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1 (initiating 1st line CDK4/6 & endocrine therapy)
Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression.
Optional blood draws will be taken with standard of care labs when starting next therapy.
|
Undergo blood sample collection
Other Names:
|
Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy)
Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression.
Optional blood draws will be taken with standard of care labs when starting next therapy.
|
Undergo blood sample collection
Other Names:
|
Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy)
Blood will be drawn on day 15 of the next cycle after enrollment and the first day of every cycle thereafter until progression.
Optional blood draws will be taken with standard of care labs when starting next therapy.
|
Undergo blood sample collection
Other Names:
|
Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)
Blood will be drawn at baseline or the first day of the treatment cycle and the first day of every cycle thereafter until progression.
Optional blood draws will be taken with standard of care labs when starting next therapy.
|
Undergo blood sample collection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DiviTum®TKa assay as an early predictor of primary treatment resistance
Time Frame: Every cycle (approximately 28 days) until disease progression up to 6 months
|
Blood samples collected from participants will be assessed using DiviTum®TKa assay for thymidine kinase activity (TKa) levels above Limit of Detection (LOD) as a predictor of primary treatment resistance.
Primary treatment resistance will be defined as disease progression in less than 6 months.
|
Every cycle (approximately 28 days) until disease progression up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pooja Advani, MBBS, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2024
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
June 15, 2026
Study Registration Dates
First Submitted
April 24, 2024
First Submitted That Met QC Criteria
April 26, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-009689
- NCI-2024-03405 (Registry Identifier: CTRP (Clinical Trials Reporting Program))
- MC240301 (Other Identifier: Mayo Clinic)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Breast Cancer
-
Gilead SciencesRecruitingStudy of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors (ASCENT-J02)Advanced Solid Tumor | Metastatic Urothelial Cancer | Metastatic Triple-Negative Breast Cancer | HR+/HER2- Metastatic Breast CancerJapan
-
GlycoMimetics IncorporatedTerminatedBreast Cancer | Breast Cancer Metastatic | HR+ Metastatic Breast CancerUnited States
-
BriaCell Therapeutics CorporationRecruitingBreast Cancer | Breast Neoplasm | Metastatic Breast Cancer | Breast Cancer Metastatic | End Stage CancerUnited States
-
OBI Pharma, IncCompletedMetastatic Colorectal Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Gastric CancerTaiwan
-
Massachusetts General HospitalPuma Biotechnology, Inc.; Celcuity, Inc.WithdrawnMetastatic Breast Cancer | Invasive Breast Cancer | HER2-negative Breast Cancer | ER Positive Breast Cancer | PR-Positive Breast Cancer | Stage IV (Metastatic) Breast CancerUnited States
-
Novartis PharmaceuticalsCompletedMetastatic Breast Cancer | Postmenopausal Women | Locally Advanced Metastatic Breast CancerIsrael
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyCompletedMetastatic Breast Cancer | Metastatic Triple Negative Breast CancerJapan, Belgium, France, Netherlands
-
Prof. Wolfgang JanniEli Lilly and CompanyRecruitingHormone Receptor-positive Metastatic Breast Cancer | HER2-negative Metastatic Breast CancerGermany, Switzerland
-
BriaCell Therapeutics CorporationLumaBridgeEnrolling by invitationBreast Cancer | Breast Neoplasm | Metastatic Breast Cancer | Breast Cancer MetastaticUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisDaiichi SankyoRecruitingAdvanced Breast Cancer | HER2-positive Metastatic Breast Cancer | Breast Cancer Metastatic | HER2 Low Breast CarcinomaFrance
Clinical Trials on Biospecimen Collection
-
LLS PedAL Initiative, LLCNational Cancer Institute (NCI); Children's Oncology GroupRecruitingAcute Myeloid Leukemia | Juvenile Myelomonocytic Leukemia | Acute Lymphoblastic Leukemia | Myelodysplastic Syndrome | Myeloid Leukemia Associated With Down Syndrome | Mixed Phenotype Acute Leukemia | Acute Myeloid Leukemia Post Cytotoxic Therapy | Myelodysplastic Syndrome Post Cytotoxic TherapyUnited States, Canada, Australia, Puerto Rico, New Zealand
-
Thomas Jefferson UniversityNational Cancer Institute (NCI)Active, not recruiting
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8United States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingBreast Adenocarcinoma | HER2-Positive Breast CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingAnatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Anatomic Stage IIIB Breast Cancer AJCC v8 | Anatomic Stage IIIC Breast Cancer AJCC v8 | Prognostic Stage III Breast Cancer AJCC v8 | Prognostic Stage IIIA Breast Cancer AJCC v8 | Prognostic Stage IIIB Breast... and other conditionsUnited States, Puerto Rico
-
Ohio State University Comprehensive Cancer CenterGuardant Health, Inc.RecruitingColorectal CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Recruiting
-
Mayo ClinicRecruitingEarly Stage Breast Carcinoma | Chemotherapy-Related Nausea and/or VomitingUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruiting
-
M.D. Anderson Cancer CenterRecruitingCholangiocarcinoma | Malignant Digestive System NeoplasmUnited States