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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 (May 2026). This Phase 2 trial studies Capecitabine Pill for metastatic breast cancer.

Phase 2RecruitingUniversity of Alabama at BirminghamNCT06105684Data as of May 2026

Treatment: Capecitabine PillThis 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.

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Extracted eligibility criteria

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)

Prior therapy

Min 1 prior line

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

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