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
Breast Cancer, Cancer of the Breast
About this trial
This is an interventional health services research trial for Breast Cancer
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 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.
- Cohort 2 only: Currently receiving first-line therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for no longer than 24 months with 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.
- Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
- Cohorts 1 and 2: Prior receipt of adjuvant CDK 4/6 inhibitor therapy is permitted provided therapy completion occurred > 12 months prior to study enrollment.
- 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.
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- 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
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort 1: Scheduled to receive first line therapy
Cohort 2: Currently receiving first line therapy
Medical Oncologists
Scheduled to receive 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient & review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes
1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor for ≤ 24 months with stable disease Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient & review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes
-Will be completing the Study Care Forms at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months.