Actively Recruiting
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
Led by Washington University School of Medicine · Updated on 2025-12-17
65
Participants Needed
1
Research Sites
522 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
B
Biovica
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic or advanced unresectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative
- Planned to start first-line FDA-approved endocrine therapy plus CDK4/6 inhibitor, preferably ribociclib, or alternative CDK4/6 inhibitor if needed
- Prior therapy for early stage breast cancer allowed, including endocrine therapy and chemotherapy
- Prior adjuvant CDK4/6 inhibitor therapy allowed if completed more than 12 months before enrollment
- Presence of RECIST-evaluable disease, including bone-only disease
- At least 18 years old
- ECOG performance status of 2 or less
- Post-menopausal status as defined by age or surgical status or ovarian suppression
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Prior cytotoxic chemotherapy for metastatic breast cancer
- Current or prior malignancy that could interfere with safety or efficacy assessment unless deemed not interfering
- Concurrent participation in any other investigational therapy trial for metastatic breast cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
K
Katherine Clifton, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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