OncoMatch/Clinical Trials/NCT05693766
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Is NCT05693766 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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 →Frequently asked questions
Is NCT05693766 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
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 qualify