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
TK IMPACT: 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: Physician Decision Impact Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding the DiviTum® blood test changes when doctors order scans or other cancer tests. It is for people with advanced breast cancer that uses hormones to grow (HR-positive) and is HER2-negative, who are starting or taking hormone therapy with a CDK 4/6 inhibitor, a drug that slows cancer growth.
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. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have breast cancer that has spread, or advanced invasive breast cancer that can be removed by surgery. It must be HR-positive and HER2-negative. Have cancer imaging within 4 weeks of the first study visit.
- Group 1: Plan to start hormone therapy plus palbociclib, ribociclib, or abemaciclib as the first combined treatment for advanced cancer.
- Group 2: Already take this combined treatment. The CDK 4/6 drug must have started within 24 months before joining. Scans must show no cancer growth for at least 12 weeks. Drug changes are allowed if they were not due to cancer growth.
- Prior treatment for early breast cancer is allowed. Either group may qualify after cancer grew or returned while taking hormone therapy alone. Prior CDK 4/6 treatment given after surgery must have ended more than 12 months before joining.
- Be at least 18 years old and expected to live more than 6 months.
- Meet the study's menopause rules: age 60 or older; under 60 with a uterus and no periods for at least 12 months; prior removal of both ovaries or the whole uterus; or ovarian function stopped by medicine or removal of both ovaries.
- Be treated at Siteman Cancer Center by a doctor in the study. You or your legal representative must understand and agree to sign the consent form.
- Doctors may join if they are Siteman Cancer Center cancer specialists, treat breast cancer that has spread or cannot be removed by surgery, and agree to complete study care plans regularly.
Who can't join
- Have had chemotherapy that kills cancer cells for breast cancer that has spread. Chemotherapy before or after surgery for early breast cancer is allowed.
- Have another past or current cancer that could affect study tests or results. Another cancer is allowed if the treating doctor and study leader agree it will not interfere.
- Are also in a trial testing a treatment for breast cancer that has spread.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 study visit. * 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 stated diagnosis at the time of study enrollment. Type of endocrine therapy and CDK 4/6 inhibitor will be documented. Patients may also be eligible if: * 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 adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment. * 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 or CDK 4/6 inhibitor agent during first-line combination therapy are permitted as long as change was not performed due to progressive disease. CDK 4/6 inhibitor must have been initiated within 24 months of study enrollment, and patient must have at least stable disease (no progression) on such therapy for a minimum of 12 weeks prior to enrollment as determined by radiographic studies as deemed appropriate by the treating physician. Type of endocrine therapy and CDK 4/6 inhibitor will be documented. Patients may also be eligible if they are receiving next line endocrine therapy plus CDK 4/6 inhibitor therapy following: * 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 enrollment. * 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. Exclusion Criteria - 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 physician and with agreement by Principal Investigator * 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
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Nusayba Bagegni, M.D. · Study contact · 314-273-3022 · nbagegni@wustl.eduNusayba Bagegni, M.D. · Principal investigatorFoluso Ademuyiwa, M.D., MPH · Sub-investigatorRon Bose, M.D. · Sub-investigatorMore trials in St Louis