OncoMatch/Clinical Trials/NCT06105684
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Is NCT06105684 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Capecitabine Pill for metastatic breast cancer.
Treatment: Capecitabine Pill — This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (ISH non-amplified and IHC 0 or 1+ or 2+) (ISH non-amplified and IHC 0 or 1+ or 2+)
HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.
Disease stage
Required: Stage IV, III
Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: hormonal therapy or chemotherapy — metastatic
Cannot have received: capecitabine (capecitabine)
Lab requirements
Blood counts
ANC >1.5 x 10⁹/L (1500/µL) or >1.3 x 10⁹/L (1300/µL) for benign ethnic neutropenia; Platelet count ≥100,000/µL; Hemoglobin ≥9.0 g/dl (transfusion/erythropoietic support allowed)
Kidney function
Creatinine clearance > 30 mL/min (Cockcroft-Gault or MDRD)
Liver function
AST, ALT, and alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver/bone metastasis); serum bilirubin ≤1.5 x ULN (≤3 x ULN for Gilbert disease)
Adequate organ function as evidenced by: ANC >1.5 x 10⁹/L (1500/µL) or > 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia. Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)). Hemoglobin ≥9.0 g/dl. Patients may be transfused or receive erythropoietic treatment to meet this criterion. AST, ALT, and alkaline phosphatase ≤2.5 x upper limit of normal (ULN) with following exceptions: I. Patients with documented liver metastasis: AST and ALT ≤5 x ULN II. Patients with documented liver or bone metastasis: alkaline phosphatase ≤5 x ULN. Serum bilirubin ≤1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled. INR and aPTT ≤1.5 x ULN. This applies only to the patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. Creatinine clearance > 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06105684 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 ERBB2?
Yes, ERBB2 negative (ISH non-amplified and IHC 0 or 1+ or 2+) is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages