HER2-negative Breast CancerNCT06388122
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
An observational study of HER2-negative Breast Cancer and Hormone-receptor-positive Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 15 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients >= 18 years old with diagnosis of metastatic HR positive HER2 negative breast cancer or early breast cancer HR positive HER2 negative that will be or are currently being treated with standard of care endocrine therapy +/- CDK 4/6 inhibitors.
Who may be able to join
- 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.
- Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials, 855-776-0015, mayocliniccancerstudies@mayo.edu
Pooja Advani, MBBS, MD
About this study
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
- Conditions
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
- Being tested
- Biospecimen Collection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (initiating 1st line CDK4/6 & endocrine therapy) | Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. Receives: Procedure: Biospecimen Collection | |
| Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy) | Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. Receives: Procedure: Biospecimen Collection | |
| Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy) | Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. Receives: Procedure: Biospecimen Collection | |
| Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy) | Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. Receives: Procedure: Biospecimen Collection | |
| Group 5 | Patients scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage II or stage III adjuvant HR+ BC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DiviTum®TKa assay as an early predictor of primary treatment resistance
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.
Measured: Every cycle (approximately 28 days) until disease progression up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start30 Apr 2024
- Primary completion15 Jun 2031 (estimated)
- Study completion15 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooja Advani, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388122
- Sponsor's protocol ID
- MC240301
- Other IDs
- 23-009689
- Status last verified
- May 2026
- First submitted
- 24 Apr 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06388122
- Acronym / sponsor ID
- MC240301
- Conditions
- HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 15 Jun 2031 (estimated)
- Study completion
- 15 Jun 2031 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 (initiating 1st line CDK4/6 & endocrine therapy) | – | Procedure: Biospecimen CollectionPatients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. |
| Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy) | – | Procedure: Biospecimen CollectionPatients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. |
| Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy) | – | Procedure: Biospecimen CollectionPatients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. |
| Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy) | – | Procedure: Biospecimen CollectionPatients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. 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. |
| Group 5 | – | Procedure: Biospecimen CollectionPatients scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage II or stage III adjuvant HR+ BC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients >= 18 years old with diagnosis of metastatic HR positive HER2 negative breast cancer or early breast cancer HR positive HER2 negative that will be or are currently being treated with standard of care endocrine therapy +/- CDK 4/6 inhibitors.
Key inclusion criteria (7 listed)
- Pre- or post-menopausal HR+ metastatic breast cancer patients who are:
- 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.
Key exclusion criteria (6 listed)
- Treatment including investigational agent or therapies
- Early breast cancer diagnosis
- Male breast cancer
- Currently receiving treatment for other active malignancy at time of registration
- Inability to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Group 1 (initiating 1st line CDK4/6 & endocrine therapy), Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy), Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy), Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy), Group 5 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pooja Advani, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-negative Breast Cancer and Hormone-receptor-positive Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.