Clareo Health | 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
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
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.
* 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.
* 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.
You may not be if
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
