Mayo Clinic
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.
PRIMARY OBJECTIVE: I. Evaluate the feasibility of adaptive therapy (AT) in hormone receptor positive metastatic breast cancer, defined as the number of patients who can achieve AT modification for 2 or more cycles. SECONDARY OBJECTIVES: I. To evaluate time to progression in patients receiving capecitabine AT defined as the interval between treatment start and tumor progression, or death in patients with no evidence of disease progression. II. Assess overall survival in patients receiving capecitabine as adaptive therapy. III. Evaluate patient related outcomes by measuring quality of life…
Inclusion Criteria: * PRE-REGISTRATION: Provide written informed consent Note: Pre-registration should occur prior to screening research blood draws being completed * PRE-REGISTRATION: Provider anticipates the patient will begin on capecitabine within 14 days or has started capecitabine within the past 42 days and has had a maximum of two cycles Note: Pre-registration should occur prior to screening research blood draws being completed REGISTRATION - INCLUSION CRITERIA * Age ≥ 18 years * Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplifica…
Undergo blood sample collection
Undergo bone scan
Given PO
Undergo CT
Undergo MRI
Ancillary studies
Arctuva estimate
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