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New treatment option for Metastatic Breast Cancer
Official title BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
ClinicalTrials.gov ID: NCT05977036
What this study is testing
What is CDK4/6 + Endocrine therapy?
CDK4/6 + Endocrine therapy is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- Patients
- Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limit to chemotherapy use in the neoadjuvant or adjuvant...
- Patients with a prior or concurrent malignancy are excluded unless that malignancy's natural history or treatment does not have the potential to...
- 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.
See the full eligibility 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...
- 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).
- 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 how well it works assessment of the...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.