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BettER Study: Biomarker-Driven Treatment for HR+ HER2- Metastatic Breast Cancer

This study, called BettER, is for people with hormone receptor-positive (HR+) and HER2-negative metastatic or unresectable breast cancer. It aims to see if using a blood test called DiviTum® TKa can help doctors decide the best treatment sooner. You would start with a standard treatment of endocrine therapy plus a CDK4/6 inhibitor (like ribociclib). Blood tests for DiviTum® TKa will be done at the beginning and again after 15 days. If your TKa levels don't go down, you might be recommended to switch to a different therapy. If they do go down, you'll continue with the initial treatment. The study will look at how long people live without their cancer growing (progression-free survival) and how many see their cancer improve (clinical benefit rate) over about 7 years.

Study design
This is an interventional study planning to enroll 65 participants. It is a prospective study, meaning participants are followed forward in time.
What's involved
You would have blood drawn for TKa testing at the start of the study and again after 15 days. Your treatment may be adjusted based on these test results.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 7 years to assess progression-free survival and clinical benefit rate.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05977036

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

Recruiting
NAAges 18+InterventionalTreatment
Washington University School of Medicine
~65 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:DiviTum® TKa assayCDK4/6 + Endocrine therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) in patients who remain on CKD4/6i (patients with suppressed TKa levels at cycle 1 day 15)
Measured over Through completion of follow-up (estimated to be 7 years)
+2 more outcomes measured

Conditions

Metastatic Breast Cancer
Unresectable Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Katherine Clifton, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Katherine Clifton, M.D.
[email protected]
314-273-3712
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
Medical Oncologist at Siteman Cancer Center.
Treating patients with metastatic or advanced unresectable breast cancer.
Willing to complete Physician Surveys during participation.

What this trial measures

  • Progression-free survival (PFS) in patients who remain on CKD4/6i (patients with suppressed TKa levels at cycle 1 day 15)Through completion of follow-up (estimated to be 7 years)

    . 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.

  • Clinical benefit rate (CBR) in patients who remain on CDK4/6iThrough completion of follow-up (estimated to be 7 years)

    CBR is defined as total number (or percentage) of patients who achieved a complete response, partial response, or had stable disease for 6 months or more.

  • Progression-free survival (PFS) in patients who switch to an alternate therapy (patients with unsuppressed TKa levels at cycle 1 day 15)Through completion of follow-up (estimated to be 7 years)

    PFS in patients with unsuppressed TKa levels is defined as from the start date of receiving CDK4/6i to the end date of next-line therapy or last date on next-line if the treatment on next-line therapy is still ongoing or date of death if death occurs on treatment.