← Back to Search

Other

TK1 Activity Test for Breast Cancer

N/A

Recruiting

Led By Nusayba Bagegni, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Currently being treated at Siteman Cancer Center by a medical oncologist participating in this trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the entire study period (estimated to be 36 months)

Awards & highlights

Study Summary

This trial will test whether incorporating a test that measures TK1 activity into the treatment monitoring schema for people with metastatic breast cancer will be associated with a reduction in the number of other routine restaging tests, including tumor imaging or tumor marker testing.

Who is the study for?

This trial is for women under 60 with HR+ and HER2- metastatic breast cancer, starting or already on FDA-approved endocrine therapy plus CDK 4/6 inhibitors. They must have a life expectancy over 6 months, be post-menopausal or have suppressed ovarian function, and not be in any other investigational treatment trials. Prior early-stage breast cancer treatments are okay.Check my eligibility

What is being tested?

The study tests if monitoring patients using the DiviTum® TKa assay can influence doctors to space out routine restaging tests like tumor imaging. The goal is to see if this leads to fewer overall tests by extending intervals between them due to low disease progression rates in these patients.See study design

What are the potential side effects?

Since the intervention involves testing with the DiviTum® TKa assay rather than a drug, traditional side effects associated with medications are not expected. However, there may be minimal risks related to blood sample collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can understand and am willing to sign a consent form.

Select...

I am currently a patient at Siteman Cancer Center under a doctor in this trial.

Select...

I am under 60, have a uterus, and haven't had a period for 12 months or more.

Select...

My breast cancer is advanced, can be surgically removed, is HR+ and HER2-.

Select...

I am 60 years old or older.

Select...

I have had both ovaries and my uterus removed.

Select...

My cancer progressed after hormone therapy for advanced cancer.

Select...

I am post-menopausal.

Select...

My cancer has worsened after hormone therapy for advanced cancer.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the entire study period (estimated to be 36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the entire study period (estimated to be 36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the entire study period (estimated to be 36 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value

Secondary outcome measures

Cohort 1 only: DiviTum® TKa level

Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values

Longitudinal changes in DiviTum® TKa value dynamics

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Medical OncologistsExperimental Treatment1 Intervention

-Will be completing the Study Care Forms at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months.

Group II: Cohort 2: Currently receiving first line therapyExperimental Treatment1 Intervention

1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor for ≤ 24 months with stable disease Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient & review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes

Group III: Cohort 1: Scheduled to receive first line therapyExperimental Treatment1 Intervention

Scheduled to receive 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient & review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,755 Total Patients Enrolled

46 Trials studying Breast Cancer

5,113 Patients Enrolled for Breast Cancer

BiovicaUNKNOWN

1 Previous Clinical Trials

65 Total Patients Enrolled

Nusayba Bagegni, M.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

81 Total Patients Enrolled

1 Trials studying Breast Cancer

81 Patients Enrolled for Breast Cancer

Media Library

Study Care Plans (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04968964 — N/A

Breast Cancer Research Study Groups: Cohort 2: Currently receiving first line therapy, Cohort 1: Scheduled to receive first line therapy, Medical Oncologists

Breast Cancer Clinical Trial 2023: Study Care Plans Highlights & Side Effects. Trial Name: NCT04968964 — N/A

Study Care Plans (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968964 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment currently open?

"Confirming the data found on clinicaltrials.gov, this medical trial is still in search of volunteers. Its original posting was dated March 7th 2022 and has since been updated as recently as July 28th 2022."

Answered by AI

What is the sample size for this experiment?

"Affirmative. According to clinicaltrials.gov, this trail is actively seeking participants to partake in the research - it was initially posted on March 7th 2022 and modified last on July 28th of that same year. Currently, 55 patients are needed across a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing

2022. "Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968964.