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NCT05977036 · ClinicalTrials.gov registry record · NA
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
A NA study of Metastatic Breast Cancer and Unresectable Breast Cancer, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05977036: Recruiting NA study of Metastatic Breast Cancer and Unresectable Breast Cancer, sponsored by Washington University School of Medicine.
NCT05977036 is a NA study of Metastatic Breast Cancer and Unresectable Breast Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 65 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05977036, a NA study of Metastatic Breast Cancer and Unresectable Breast Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with HR positive, HER-2 negative metastatic or unresectable breast cancer. Patients will receive first-line treatment with a CDK4/6 inhibitor (CDK4/6i) and endocrine therapy. All patients will have blood drawn for thymidine kinase activity (TKa) testing at baseline and at C1D15. Patients who are found to have a lack of TKa suppression at C1D15 will be recommended to switch to an alternative therapy. Patients with suppressed C1D15 TKa levels will continue on CDK4/6i and endocrine therapy until clinical progression. Patients with TKa which remains suppressed will be recommended to delay restaging scans from 24 weeks to 36 weeks. The investigators hypothesize that a patient's TKa level at C1D15 is prognostic for progression-free survival (PFS) on a CDK4/6 inhibitor and early therapeutic switching in patients with a lack of C1D15 TKa suppression will be associated with prolonged PFS.
Primary Outcome
. PFS in patients with suppressed TKa levels is defined as from the start date of receiving CDK4/6i to the end date of CDK4/6i or last date on CDK4/6i if the treatment on CDK4/6i is still ongoing or date of death if death occurs on treatment.
Conditions Studied
Interventions
- DEVICE DiviTum® TKa assay
- DRUG CDK4/6 + Endocrine therapy
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2034-09-30 |
| Phase | NA |
What NCT05977036 shows while recruiting
NCT05977036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which DiviTum® TKa assay is the first listed.
NCT05977036 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05977036 about?
NCT05977036 is a clinical study titled "BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer". This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with HR positive, HER-2 negative metastatic or unresectable breast cancer. Patients will receive fi...
What is the current status of trial NCT05977036?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2024-09-25. Estimated completion is 2034-09-30.
What conditions does trial NCT05977036 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Unresectable Breast Cancer.
What interventions are being tested in trial NCT05977036?
The interventions under investigation include: DiviTum® TKa assay (DEVICE), CDK4/6 + Endocrine therapy (DRUG).
Who is sponsoring clinical trial NCT05977036?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05977036 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05977036's enrollment target sits among peer trials
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