BridgeMD
New treatment option for Breast Cancer
Official title Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
ClinicalTrials.gov ID: NCT04968964
What this study is testing
- What it's testing
- Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated.
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 resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by...
- Cohort 1 only: Scheduled to initiate standard of care first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved...
- Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR
- Patients initiated endocrine therapy alone with ultimate intention to add CDK 4/6 inhibitor therapy, OR
You likely can't join if
- Patients:
- Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol...
- 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 invasive breast cancer
See the full eligibility criteria
- Patients:
- Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline...
- Cohort 1 only: Scheduled to initiate standard of care first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the...
- Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR
- Patients initiated endocrine therapy alone with ultimate intention to add CDK 4/6 inhibitor therapy, OR
- Patients recurred on adjuvant endocrine therapy monotherapy and are scheduled to receive next line endocrine therapy combined with CDK 4/6 inhibitor. Patients may have also received CDK 4/6 inhibitor therapy in the...
- Cohort 2 only: Currently receiving first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib). Changes in endocrine therapy...
- Progression on prior endocrine therapy monotherapy in the metastatic setting, OR
- Recurrence on adjuvant endocrine therapy monotherapy. Patients may have also received CDK 4/6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study...
- Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
- At least 18 years of age.
- Life expectancy \> 6 months.
- 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).
- Currently being treated at Siteman Cancer Center by a medical oncologist participating in this trial.
- Patients:
- Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol assessments or analyses are eligible for this trial as determined by treating...
- 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 invasive breast cancer
- Willing to complete Study Care Plans on a serial basis 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.