OncoMatch/Clinical Trials/NCT06568692
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Is NCT06568692 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PCS6422 and capecitabine and Capecitabine for breast cancer.
Treatment: PCS6422 and capecitabine · Capecitabine — This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Excluded: DPYD homozygous or compound heterozygous variants that result in complete or near-complete absence of DPD activity
Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: taxane — resistant or intolerant
resistant or intolerant to taxanes
Must have received: anthracycline — resistant or intolerant
resistant or intolerant to ... an anthracycline-containing regimen
Cannot have received: any treatment for advanced or metastatic breast cancer
Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
Cannot have received: hormone replacement therapy
Exception: unless discontinued within 21 days prior to randomization
Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
Cannot have received: IV 5-FU or oral 5-FU analog
Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
Cannot have received: DPD inhibitor
Received DPD inhibitor within 4 weeks prior to C1D1
Lab requirements
Blood counts
Hemoglobin ≥9 g/dL; Peripheral ANC ≥1.5×10^9/L; Platelet count ≥100×10^9/L without growth factor/transfusion
Kidney function
Adequate renal function by eGFR defined as a creatinine clearance >50 mL/min (Cockcroft-Gault equation) and normalized to body surface area
Liver function
Total bilirubin <1.5× ULN; or ≤3×ULN if the patient has Gilbert's disease; AST or ALT <2.5×ULN, with liver metastasis <5×ULN
Cardiac function
No history or presence of clinically significant abnormal ECG; QTc (Fridericia) ≤480 msec; No history of prolonged QTc interval, ventricular tachycardia/fibrillation or significant ventricular arrhythmia, Torsades de Pointes, or ventricular ablation for arrhythmia; No congenital long QT syndrome or family history of long QT syndrome; No other clinically significant cardiac disease including, but not limited to, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery ≤12 months prior to randomization, congestive heart failure (Class II per NYHA), or history of myocarditis
Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements... (see full text for details); Cardiac: see exclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Oncology Associates · Tucson, Arizona
- Valkyrie Clinical Trials · Los Angeles, California
- FOMAT Medical Research · Oxnard, California
- AP Medical Research · Miami, Florida
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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