OncoMatch/Clinical Trials/NCT07222215
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Is NCT07222215 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Capecitabine and Elacestrant for estrogen-receptor-positive breast cancer.
Treatment: Capecitabine · Elacestrant — The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4/6 inhibitors, including palbociclib, ribociclib, or abemaciclb. The names of the study drugs involved in this study are: * Elacestrant (a type of selective estrogen receptor degrader) * Capecitabine (a type of fluoropyrimidine antimetabolite)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
HER2-negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — metastatic setting or recurrence on/within one year of adjuvant endocrine therapy
Must have progressed on at least one line of endocrine therapy in the metastatic setting or recurred on or within one year of adjuvant endocrine therapy
Must have received: CDK4/6 inhibitor — adjuvant or metastatic disease
Prior CDK4/6 inhibition is required (in adjuvant or metastatic disease), unless a CDK4/6 inhibitor is contraindicated
Cannot have received: chemotherapy
Exception: no prior chemotherapy regimen or ADC is allowed in the metastatic setting
No prior chemotherapy regimen or ADC is allowed in the metastatic setting
Cannot have received: oral SERD or next generation oral endocrine therapy
Neither prior oral SERDs nor other next generation oral endocrine therapies (such as PROTACS) are permitted
Lab requirements
Blood counts
Absolute neutrophil count > 1,500/µL; Platelets > 100,000/µL; Hemoglobin > 9 g/dL (transfusion is allowed to meet this criterion)
Kidney function
Creatinine clearance > 50 mL/min/1.73 m2
Liver function
Total bilirubin < 1.5 x institutional ULN or < 3 institutional ULN in the presence of documented Gilbert's syndrome; AST (SGOT)/ALT (SGPT) < 2.5 x institutional ULN, or ≤ 5 institutional ULN for subjects with documented metastatic disease to the liver
Adequate hematological, liver, and kidney function, as defined below: Absolute neutrophil count > 1,500/µL; Platelets > 100,000/µL; Hemoglobin > 9 g/dL (transfusion is allowed to meet this criterion) Total bilirubin < 1.5 x institutional upper limit or normal (ULN) or < 3 institutional ULN in the presence of documented Gilbert's syndrome; AST (SGOT)/ALT (SGPT) < 2.5 x institutional ULN, or ≤ 5 institutional ULN for subjects with documented metastatic disease to the liver; Creatinine clearance > 50 mL/min/1.73 m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07222215 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, oral SERD or next generation oral endocrine therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
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