OncoMatch/Clinical Trials/NCT06525766
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
Is NCT06525766 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Capecitabine for anatomic stage iv breast cancer ajcc v8.
Treatment: Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive)
estrogen-receptor positive (ER+)
Required: HER2 (ERBB2) overexpression (negative)
HER2-negative overexpression or amplification negative as per ASCO/CAP guidelines
Required: HER2 (ERBB2) amplification (negative)
HER2-negative overexpression or amplification negative as per ASCO/CAP guidelines
Excluded: DPYD homozygous or compound heterozygous variants resulting in complete absence of DPD activity
Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: in the metastatic setting
Prior chemotherapy or use of antibody drug conjugate in the metastatic setting
Cannot have received: antibody-drug conjugate
Exception: in the metastatic setting
Prior chemotherapy or use of antibody drug conjugate in the metastatic setting
Cannot have received: major surgery
Exception: ≤ 3 weeks prior to registration
Major surgery ≤ 3 weeks prior to registration
Cannot have received: radiation therapy
Exception: ≤ 2 weeks prior to registration
Radiation therapy ≤ 2 weeks prior to registration
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3; Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement); Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
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