💬In plain words
What the trial is, and whether it could suit you
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 hormone receptor (HR) positive, HER-2 negative metastatic or unresectable breast cancer receiving first-line or second-line treatment.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria - Patients
* Diagnosis of metastatic or advanced unresectable invasive breast cancer with MD intent to treat as HR-positive and HER2-negative, with the following arm-specific requirements:
* Arm 1: Patient must be planning 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. Note: Ribociclib is the preferred CDK4/6 inhibitor, but alternative CDK4/6 inhibitors are allowed. Note: Initiation of endocrine therapy prior to ultimate plan for addition of CDK4/6 inhibitor is permitted prior to enrollment.
* Arm 2: patient must be planning to initiate standard of care second-line therapy with FDA-approved endocrine therapy plus CDK4/6 inhibitor for the stated diagnosis at the time of study enrollment. Triplet regimens are permitted as long as they contain CDK4/6 inhibitor and endocrine therapy. Note: Initiation of endocrine therapy prior to ultimate plan for addition of CDK4/6 inhibitor is permitted prior to enrollment.
* Arm 3: patient must be planning to initiate first- or second-line therapy for the stated diagnosis at the time of study enrollment with therapy other than endocrine therapy plus 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 with the following arm-specific requirements:
* Arm 1: CDK4/6 inhibitor may have been given only in the neoadjuvant/adjuvant setting (not metastatic setting), and the last dose must have been \> 12 months prior to study enrollment.
* Arms 2 and 3: No restrictions on prior CDK4/6 inhibitors.
* Measurable or non-measurable disease per RECIST v1.1.
* At least 18 years of age.
* ECOG PS ≤ 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).
Exclusion Criteria - 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.
* Prior or concurrent malignancy (unless that malignancy's natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen).
* Arms 1 and 2: 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.