This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
Primary Objective: \- Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Secondary Objectives: * Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer * Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Correlatives: * Determine if the tumor mutations detected in cfDNA are early surrogates of response * Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
2000 mg taken by mouth twice daily for 7 days on, 7 days off
Endocrine therapy administered
Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays
University of Alabama Birmingham
Birmingham, Alabama, United States
RECRUITINGVanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
RECRUITINGUT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGProgression free survival
Time frame: Up to 3 years
Overall survival at 2 years
Time frame: Up to 2 years
Overall survival at 5 years
Time frame: Up to 5 years
Overall survival at 10 years
Time frame: Up to 10 years
Clinical Benefit Rate
Percentage of patients without disease progression at 6 months
Time frame: Approximately 6 months
Overall response rate
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 28 days post-treatment
Overall impact of treatment toxicity
Will be measured using Functional Assessment of Cancer Therapy (FACT)-G (5 point Likert-type scale from 1 ("none at all") to 5 ("very much")
Time frame: Up to 3 years
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