OncoMatch/Clinical Trials/NCT05693766
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Is NCT05693766 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Capecitabine for invasive mammary carcinoma.
Treatment: Capecitabine — This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER (≥1%) by IHC)
ER (≥1%) and/or PR (≥ 1%) by IHC
Required: PR (PGR) overexpression (PR (≥1%) by IHC)
ER (≥1%) and/or PR (≥ 1%) by IHC
Required: HER2 (ERBB2) wild-type (HER2 negative (by IHC or FISH))
HER2 negative (by IHC or FISH)
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: aromatase inhibitor
Previously exposed to an aromatase inhibitor (AI)
Must have received: selective estrogen receptor modulator
selective estrogenreceptor modulator/ downregulator (SERM; SERD)
Must have received: CDK4/6 inhibitor
CDK4/6 inhibitor
Cannot have received: chemotherapy
Exception: not in the metastatic setting
Prior chemotherapy in the metastatic setting
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 8/g/dL (may have been transfused)
Kidney function
Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation
Liver function
Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN); AST/SGOT and ALT/SGPT ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
Adequate organ function including: ANC ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 8/g/dL (may have been transfused); Total serum bilirubin ≤ 1.5 times ULN; AST/SGOT and ALT/SGPT ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present); Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama Birmingham · Birmingham, Alabama
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
- UT Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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