OncoMatch/Clinical Trials/NCT07222215
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Is NCT07222215 recruiting? Yes, currently enrolling (May 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
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 mutation status testing required
Participants must have standard of care testing documenting ESR1 mutation status.
Required: ESR1 expression ≥ 10% (≥ 10%)
ER must be ≥ 10% on the most recent biopsy in which receptor testing was performed.
Required: HER2 (ERBB2) negative (negative)
HER2- negative
Allowed: ESR1 E380Q
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 V422del
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 S436P
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 L536H
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 L536P
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 L536R
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 Y537C
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 Y537D
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 Y537N
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 Y537S
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 D538G
qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
Allowed: ESR1 wild-type
In patients without ESR1 mutation, this result must be from within 2 months.
Disease stage
Metastatic disease required
metastatic or locally recurrent unresectable (advanced) invasive breast cancer; Must have measurable or evaluable disease by RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — metastatic or adjuvant
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
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 is allowed in the metastatic setting.
No prior chemotherapy regimen is allowed in the metastatic setting.
Cannot have received: elacestrant (elacestrant)
Prior elacestrant is NOT permitted, but prior other oral SERD is 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 > 30 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN
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
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 →
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