St Louis, MONCT05977036Now EnrollingIRB Ready

Metastatic Breast Cancer Clinical Trial in St Louis, MO

Access cutting-edge metastatic breast cancer treatment through this clinical trial at a research site in St Louis. Study-provided care at no cost to qualified participants.

Sponsored by Washington University School of Medicine

Quick Self-Assessment

See if you qualify for this St Louis location

Preparing your pre-screening questions…

Expert Care in St Louis

Access metastatic breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic breast cancer treatment provided free

Apply for This St Louis Location

Check if you qualify for this metastatic breast cancer clinical trial in St Louis, MO

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to St Louis

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit St Louis site if eligible
  4. 4Begin participation

About This Metastatic Breast Cancer Study in St Louis

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.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT05977036) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Breast Cancer Treatment Options in St Louis, MO

If you're searching for metastatic breast cancer treatment options in St Louis, MO, this clinical trial (NCT05977036) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic breast cancer clinical trials near you to find additional studies recruiting in your area.

More Breast Cancer Trials in St Louis, MO

See all breast cancer clinical trials recruiting in St Louis — not just this study.

Browse Breast Cancer Trials in St Louis →

Browse More Trials by Condition

Breast Cancer TrialsEssential Tremor TrialsAnkylosing Spondylitis TrialsInterstitial Cystitis TrialsMyalgic Encephalomyelitis TrialsAll Conditions →

Ready to Join in St Louis?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · St Louis, MO