Phase
Condition
Breast Cancer
Treatment
ctDNA-Guided Treatment Strategy
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specificscreening procedure.
Patient is ≥ 18 years-old at the time of ICF signature.
Patient is female with known menopausal status at the time of initiation of adjuvantendocrine therapy (ET), or male.
Patient with histologically confirmed unilateral and unifocal primary invasiveadenocarcinoma of the breast prior to initiating adjuvant chemotherapy, ifindicated, or within 6 months of initiating adjuvant endocrine therapy ifchemotherapy is not indicated. Patients who receive neoadjuvant endocrine therapy orchemotherapy are allowed to enroll.
Patient has breast cancer that is positive for ER and/or PR according to the locallaboratory as determined on the most recently analyzed tissue sample.
Patient has HER2-negative breast cancer defined as a negative in situ hybridizationtest (FISH, CISH, or SISH) or an immunohistochemistry (IHC) status of 0 or 1+. IfIHC is 2+, a negative in situ hybridization (ISH) test is required to confirm theHER2-negative status.
Patient has available archival tumor tissue from the diagnostic biopsy or surgicalspecimen, for submission to a central laboratory for Signatera testing (unlessSignatera Genome clinical testing has already been performed).
Patient after surgical resection where tumor was removed completely (i.e., negativemicroscopic margins on final pathology) and have Anatomic Stage II that is either:
N1 or,
If N0, T2 or T3 with G2-3 and/or Ki67≥20% (testing for Ki67 not mandatory),excluding G1. Notes:
Patients who received neoadjuvant treatment must meet the criteria for stage,grade, Ki67 in any presurgical staging/sample and/or in the surgical specimen.
Categorization into the AJCC 8th edition Anatomic Stage Groups requiresdetermination of the T, N and M categories. ALND can be omitted.
Patient has no contraindication to adjuvant ET and is planned to be treated with ETfor 5 years (since enrollment date) or more.
Provider and patient must be agreeable to initiate CDK4/6 inhibitors only upon ctDNAdetection.
Patient may have received up to 6 months of standard adjuvant ET at the time ofenrollment and any amount of neoadjuvant endocrine therapy.
Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
Patient must not have a clinical contraindication to ribociclib or abemaciclib.
Patient must be willing and able to comply with scheduled visits, treatment plans,laboratory tests, and other trial procedures.
Women of childbearing potential (CBP) must have a confirmed negative serum pregnancytest within 14 days prior to enrollment.
Women of reproductive potential should be advised of the potential risk of CDK4/6inhibitors to a fetus, and use effective contraception during CDK 4/6 inhibitortherapy.
Exclusion
Exclusion Criteria:
Patient has had prior exposure to a CDK4/6 inhibitor.
Patient is concurrently using hormone replacement therapy.
Patient with a known contraindication or hypersensitivity to ribociclib orabemaciclib as per the FDA indication label.
Patients with a multicentric and/or multifocal and synchronous contralateral breastcancer are ineligible.
Patient with distant metastases of breast cancer beyond regional lymph nodes (stageIV according to AJCC 8th edition) and/or evidence of recurrence after curativesurgery.
Patient has a concurrent invasive malignancy or a prior invasive malignancy whosetreatment was completed within 5 years before ICF signature. Note: Patients withprior or concurrent in situ malignancies are eligible provided that adequatecurative treatment is completed prior to enrollment.
Patient has any other concurrent severe and/or uncontrolled medical condition thatwould, in the Investigator's judgment, cause unacceptable safety risks,contraindicate patient participation in the clinical trial or compromise compliancewith the protocol (e.g. chronic pancreatitis, chronic active hepatitis, livercirrhosis or any other significant liver disease, active untreated or uncontrolledfungal, bacterial or viral infections, active infection requiring systemicantibacterial therapy, etc.) or limit life expectancy to ≤5 years.
Patient participated in another interventional study and received treatment with aninvestigational product (or used an investigational device) within 30 days prior toenrollment or within 5 half-lives of the investigational product, whichever islonger.