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CDK4/6 Inhibitor

Biomarker-Driven Therapy for Breast Cancer

N/A

Waitlist Available

Led By Katherine Clifton, 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

At least 18 years of age

ECOG performance status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 7 years)

Awards & highlights

Study Summary

This trial will assess if measuring and acting on a biomarker (TKa) can help extend the progression-free survival of HR+ HER2- metastatic breast cancer patients on CDK4/6i and endocrine therapy.

Who is the study for?

This trial is for post-menopausal women with HR+ HER2- metastatic or unresectable breast cancer. They must be at least 18, have a performance status ≤ 2, and can't have had chemotherapy for metastatic disease. Prior therapy for early-stage breast cancer is okay if it was over a year ago.Check my eligibility

What is being tested?

The study tests whether changing treatments based on TKa levels from the DiviTum® assay leads to longer progression-free survival in patients using CDK4/6 inhibitors and endocrine therapy as first-line treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, CDK4/6 inhibitors commonly include fatigue, nausea, hair thinning, diarrhea, low blood cell counts leading to increased infection risk; endocrine therapies may cause hot flashes and joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My breast cancer is advanced, cannot be surgically removed, is HR+ and HER2-.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 7 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 7 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 7 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical benefit rate (CBR) in patients who remain on CDK4/6i

Progression-free survival (PFS) in patients who remain on CKD4/6i (patients with suppressed TKa levels at cycle 1 day 15)

Progression-free survival (PFS) in patients who switch to an alternate therapy (patients with unsuppressed TKa levels at cycle 1 day 15)

Secondary outcome measures

Baseline TKa level to predict overall survival (OS) on first-line CDK4/6i

Baseline TKa level to predict overall survival (OS) on later lines of therapy

Cycle 1 day 15 TKa level to predict overall survival (OS) on first-line CDK4/6i

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TKa unsuppressed at Cycle 1 Day 15Experimental Treatment2 Interventions

Study visits will occur at Baseline, Week 2 (C1D15), C2D1, C4D1, and clinical progression. Blood serum samples will be collected and analyzed using DiviTum® TKa at each of these dictated time points. Patients with lack of TKa suppression at C1D15 (defined as >145 DuA) will be recommended to switch to an alternative therapy after compliance with the medication is ensured (by pill count) and potential drug-drug interactions are reviewed. These patients will have TKa samples drawn at initiation of second-line therapy and on the first day of subsequent cycles until progression.

Group II: TKa suppressed at Cycle 1 Day 15Experimental Treatment2 Interventions

Study visits will occur at Baseline, Week 2 (C1D15), C2D1, C4D1, and clinical progression. Blood serum samples will be collected and analyzed using DiviTum® TKa at each of these dictated time points. Patients with suppressed TKa levels at C1D15 will continue on CDK4/6i + endocrine therapy until clinical progression. There will be an option to elongate the time between restaging scans from Q3M to Q6M if TKa remains suppressed in this group. Physicians may repeat TKa in 2 weeks if TKa rise is noted and if TKa again becomes suppressed, may delay imaging. These patients will undergo TKa level monitoring at C2D1, C4D1, every 3 months thereafter, and at the time of clinical progression. The feasibility endpoint relates specifically to the Week 24 imaging time point.

Group III: PhysiciansActive Control1 Intervention

-Physicians will be asked to complete surveys as follows: Physician Survey 1 for patients in the TKa C1D15 Suppressed group who have the option to delay the Week 24 scan at Week 24 Physician Survey 2 for patients in the TKa C1D15 Unsuppressed group at C1D15 (after TKa results have returned but before switching therapy)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,630 Total Patients Enrolled

47 Trials studying Breast Cancer

5,168 Patients Enrolled for Breast Cancer

BiovicaUNKNOWN

1 Previous Clinical Trials

55 Total Patients Enrolled

1 Trials studying Breast Cancer

55 Patients Enrolled for Breast Cancer

Katherine Clifton, M.D.Principal InvestigatorWashington University School of Medicine

2 Previous Clinical Trials

328 Total Patients Enrolled

Media Library

CDK4/6 + Endocrine therapy (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05977036 — N/A

Breast Cancer Research Study Groups: TKa suppressed at Cycle 1 Day 15, TKa unsuppressed at Cycle 1 Day 15, Physicians

Breast Cancer Clinical Trial 2023: CDK4/6 + Endocrine therapy Highlights & Side Effects. Trial Name: NCT05977036 — N/A

CDK4/6 + Endocrine therapy (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05977036 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants being recruited for this experiment at the moment?

"This study is no longer recruiting participants, as evidenced by the clinicaltrials.gov information. The trial having been initially posted on September 30th 2023 and last updated July 27th 2023. Fortunately, there are still 2380 other medical trials actively searching for volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05977036.