OncoMatch/Clinical Trials/NCT07631052
Capecitabine in ER+/HER2-negative Breast Cancer
Is NCT07631052 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Capecitabine for er-positive, her2-negative breast cancer.
Treatment: Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
ER-positive
Required: HER2 (ERBB2) wild-type (negative)
HER2-negative
Excluded: DPYD variant
absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: adjuvant endocrine therapy — adjuvant
Received at least 24 months of adjuvant endocrine therapy
Must have received: aromatase inhibitor — adjuvant
including 6 months of an aromatase inhibitor
Must have received: CDK4/6 inhibitor — adjuvant
Received at least 12 months of adjuvant CDK4/6i if indicated, unless not tolerated or declined
Cannot have received: capecitabine (capecitabine)
Prior therapy with capecitabine
Lab requirements
Blood counts
ANC > 1.0 x 10^9/L; Hemoglobin > 90 g/L or > 9g/dL; Platelets > 75 x 10^9/L
Kidney function
Serum creatinine < 1.5 x ULN or a calculated creatinine clearance of > 50mL/min using the Cockcroft-Gault formula
Liver function
Total bilirubin 1.5 2 ULN and < 35 uMol/L; OR total bilirubin >1.5 2 ULN with indirect bilirubin < 1.5 2 ULN. AST/SGOT and ALT/SGPT < 2.5 x ULN.
Patient must have adequate organ function as determined by the following: Renal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance of > 50mL/min using the Cockcroft-Gault formula; Bone marrow function: ANC > 1.0 x 10^9/L; Hemoglobin > 90 g/L or > 9g/dL; Platelets > 75 x 10^9/L; Liver function: Total bilirubin ≤ 1.5 × ULN and < 35 uMol/L; OR total bilirubin >1.5 × ULN with indirect bilirubin < 1.5 × ULN. AST/SGOT and ALT/SGPT < 2.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07631052 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior capecitabine disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with DPYD alterations eligible?
No. DPYD variant is an exclusion criterion.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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