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Trial Title:
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
NCT ID:
NCT05977036
Condition:
Metastatic Breast Cancer
Unresectable Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
ER+ HER2- metastatic breast cancer
biomarkers
thymidine kinase
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
DiviTum® TKa assay
Description:
Will be utilized for determination of serum enzymatic activity of TK1 according to the
manufacturer's instructions
Arm group label:
TKa suppressed at Cycle 1 Day 15
Arm group label:
TKa unsuppressed at Cycle 1 Day 15
Intervention type:
Drug
Intervention name:
CDK4/6 + Endocrine therapy
Description:
FDA-approved endocrine therapy plus CDK4/6 inhibitor. Ribociclib is the preferred CDK4/6
inhibitor. In the event this drug cannot be obtained due to insurance authorization or if
there are specific side effect profile concerns from the treating physician, an
alternative CDK4/6 inhibitor is allowed.
Arm group label:
TKa suppressed at Cycle 1 Day 15
Arm group label:
TKa unsuppressed at Cycle 1 Day 15
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria - Patients
- Diagnosis of metastatic or advanced unresectable invasive breast cancer that is
hormone receptor-positive (HR+) and HER2-negative.
- Planned to initiate standard of care first-line therapy with FDA-approved endocrine
therapy plus CDK4/6 inhibitor for the stated diagnosis at the time of study
enrollment. Ribociclib is the preferred CDK4/6 inhibitor. In the event this drug
cannot be obtained due to insurance authorization or if there are specific side
effect profile concerns from the treating physician, an alternative CDK4/6 inhibitor
is allowed.
- Any prior therapy for early stage breast cancer is allowed, including endocrine
therapy and chemotherapy.
- Prior receipt of adjuvant CDK 4/6 inhibitor therapy is permitted provided therapy
completion occurred > 12 months prior to study enrollment.
- Presence of RECIST-evaluable disease. Patients with bone-only disease are eligible.
- At least 18 years of age.
- ECOG performance status ≤ 2
- Post-menopausal status, defined as one of the following:
- Age ≥ 60 years
- Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more
- Status post bilateral oophorectomy, total hysterectomy
- Pre- or peri-menopausal with suppressed ovarian function by use of GnRH
agonist/antagonist or surgical bilateral oophorectomy
- Ability to understand and willingness to sign an IRB approved written informed
consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria - Patients
- Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will
be no limit to chemotherapy use in the neoadjuvant or adjuvant setting.
- Patients with a prior or concurrent malignancy are excluded unless that malignancy's
natural history or treatment does not have the potential to interfere with the
safety or efficacy assessment of the investigational regimen are eligible for this
trial.
- Concurrent participation in any investigational therapeutic trial for treatment of
metastatic breast cancer.
Eligibility Criteria - Physicians
- Medical Oncologist at Siteman Cancer Center.
- Treating patients with metastatic or advanced unresectable breast cancer.
- Willing to complete Physician Surveys during participation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherine Clifton, M.D.
Phone:
314-273-3712
Email:
k.clifton@wustl.edu
Investigator:
Last name:
Katherine Clifton, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Cynthia X Ma, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mark Watson, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jingqin (Rosy) Luo, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Nusayba Bagegni, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Kelly Bolton, M.D.
Email:
Sub-Investigator
Start date:
September 25, 2024
Completion date:
September 30, 2034
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Biovica
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05977036
http://www.siteman.wustl.edu
