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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jul 27, 2023

Keywords

ClinConnect Summary

The BettER clinical trial is studying how a specific blood test can help doctors choose the best treatment for women with advanced breast cancer that is hormone receptor-positive and HER2-negative. The trial focuses on patients who are starting their first treatment with a combination of approved hormone therapy and a CDK4/6 inhibitor (a type of targeted therapy). By measuring a substance in the blood called thymidine kinase (TKa) at the beginning of treatment and after 15 days, the researchers hope to determine how well the treatment is working. If the TKa levels remain high, doctors may recommend switching to a different treatment earlier, which could help patients live longer without their cancer getting worse.

To be eligible for the trial, participants must be at least 18 years old, diagnosed with this specific type of advanced breast cancer, and plan to start first-line treatment. They should also be post-menopausal and have a specific performance status that indicates they can handle the treatment. Those interested can expect regular blood tests and close monitoring during the trial, which aims to improve treatment decisions and outcomes for patients with this challenging condition.

Gender

ALL

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.