This is a Phase 2 study for patients with resected Stage I-III HR+/HER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo/adjuvant and locoregional therapy delivered with curative intent. In this study participants will be treated with capecitabine. Capecitabine will be administered orally at a dose of 500 mg 3 times daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from receiving capecitabine rather than having no change in treatment if MRD is detected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Capecitabine 500 mg
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGClearance rate of ctDNA at 16 weeks after the use of metronomic capecitabine measured using the Pathlight assay in patients with molecular residual disease (MRD). ctDNA clearance is defined as no detection of plasma ctDNA.
Time frame: Following Week 16 of treatment
Distant recurrence free survival (DRFS).
Describe clinical outcomes for MRD+ patients treated with this escalated strategy, including distant recurrence free survival (DRFS).
Time frame: Time of consent signed through to follow up (up to 5 years)
Number and severity of treatment related adverse events as assessed by CTCAE v5.0.
Time frame: Time of consent signed through to 30 days last dose of study drug
Measure ctDNA levels in MRD positive patients using the Pathlight assay after initiation of metronomic capecitabine.
Time frame: Time of consent signed through study completion, approximately 3 years
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