What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as CDK 4/6 inhibitors and HER2-targeted therapies, have a range of side effects. CDK 4/6 inhibitors can cause neutropenia, anemia, fatigue, nausea, and diarrhea. HER2-targeted therapies, including trastuzumab and its biosimilars, may lead to cardiac toxicities, infusion reactions, and mild to moderate treatment-emergent adverse events. Monitoring for these side effects is crucial to manage and mitigate their impact on patients.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer that are relevant to the context of the DiviTum® TKa assay include CDK 4/6 inhibitors such as palbociclib, which is used for hormone receptor-positive, HER2-negative metastatic breast cancer. These treatments often require monitoring through physical exams, symptom evaluation, laboratory testing, and imaging. The DiviTum® TKa assay aims to measure TK1 activity to inform treatment monitoring and potentially reduce the frequency of routine diagnostic tests, thereby lessening the burden on patients and healthcare systems.

What other types of research exist?

Promising novel alternatives to the DiviTum® TKa assay for breast cancer patients include circulating tumor DNA (ctDNA) analysis, which allows for the detection of actionable mutations and monitoring of treatment response, and advanced imaging techniques such as liquid biopsy-based imaging. Additionally, other emerging biomarkers like circulating tumor cells (CTCs) and novel genomic assays are also being explored for their potential to provide real-time insights into tumor dynamics and treatment efficacy.

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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.

Must not have

Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new blood test called DiviTum® TKa for patients with advanced breast cancer. The test measures a substance related to cancer, which could help doctors reduce the number of other routine tests and scans needed. DiviTum® TKa has been studied in other types of cancer patients treated with special therapies.

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.

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.

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

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

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

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

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

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I am 60 years old or older.

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I have had both ovaries and my uterus removed.

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My cancer progressed after hormone therapy for advanced cancer.

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I am post-menopausal.

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My cancer has worsened after hormone therapy for advanced cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received chemotherapy for cancer that has spread.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Longitudinal changes in DiviTum® TKa value dynamics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hormone receptor-positive, HER2-negative metastatic breast cancer include CDK 4/6 inhibitors (e.g., palbociclib) and hormone therapies (e.g., fulvestrant). CDK 4/6 inhibitors work by blocking cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression, thereby inhibiting cancer cell proliferation. Hormone therapies like fulvestrant degrade estrogen receptors, reducing the growth signals in hormone receptor-positive cancer cells. These treatments are significant for patients as they target specific pathways involved in cancer growth, potentially improving outcomes and allowing for more personalized treatment strategies. Monitoring tools like the DiviTum® TKa assay can help optimize these therapies by providing real-time insights into treatment efficacy, potentially reducing the need for frequent diagnostic tests and improving patient quality of life.

Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant.Phase I study of alpelisib (BYL-719) and trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer (MBC) after trastuzumab and taxane therapy.Effectiveness of Practices To Increase Timeliness of Providing Targeted Therapy for Inpatients with Bloodstream Infections: a Laboratory Medicine Best Practices Systematic Review and Meta-analysis.