Actively Recruiting
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Led by Kristina A. Fanucci · Updated on 2026-01-22
297
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
K
Kristina A. Fanucci
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable invasive breast cancer.
- ER must be at least 10% on the most recent biopsy; HER2 status per current guidelines.
- Participants must have standard testing documenting ESR1 mutation status; if no ESR1 mutation, test must be within 2 months.
- Qualifying ESR1 mutations include E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G.
- Women or men aged 18 years or older.
- Women must be postmenopausal or meet specific criteria if premenopausal, including use of GnRH agonist.
- Must have measurable or evaluable disease by RECIST 1.1 and have progressed on at least one line of endocrine therapy in metastatic setting or recurred within one year of adjuvant therapy.
- Up to two prior endocrine therapies allowed in advanced disease; prior CDK4/6 inhibitor use required unless contraindicated.
- Must have remained on prior endocrine treatment (alone or with CDK4/6 inhibitor) in metastatic setting without progression for at least 6 months before study entry.
- Prior use of alpelisib, everolimus, capivasertib with endocrine treatment allowed.
- Prior fulvestrant permitted; prior elacestrant not permitted; other oral SERDs permitted.
- No prior chemotherapy in metastatic setting.
- Radiotherapy allowed if completed over 14 days before registration and without significant toxicities.
- ECOG performance status 0-1.
- Adequate blood, liver, and kidney function per specified laboratory values.
- Women of childbearing potential, women made postmenopausal via GnRH agonists, and men must use adequate contraception during and for 6 months after treatment.
- Negative pregnancy test for premenopausal women with intact uterus.
- Ability to swallow and retain oral medication.
- Ability and willingness to provide informed consent.
- HIV-infected participants must have well-controlled HIV on ART with specific criteria.
- Participants with controlled hepatitis B or C infection under specified conditions are eligible.
You will not qualify if you...
- Endocrine or biologic therapy less than 14 days before study or unresolved treatment-related toxicities greater than grade 1 (except specified exceptions).
- Receiving concurrent investigational agents.
- Rapidly progressing symptomatic visceral disease posing short-term life-threatening risk.
- History of dihydropyrimidine dehydrogenase (DPD) deficiency.
- Active brain metastases; treated brain metastases allowed if asymptomatic and meeting washout criteria; leptomeningeal disease excluded.
- Uncontrolled illnesses including infection, significant cardiovascular disease, uncontrolled diabetes, gastrointestinal disorders affecting elacestrant absorption, psychiatric illness limiting compliance.
- Active hepatitis B or C infection.
- History of other malignancies unless disease-free for at least 3 years or certain cancers treated within 5 years.
- Use of drugs sensitive to P-glycoprotein or BCRP that may interact with study drugs.
- Treatment with strong CYP3A inhibitors within 2 weeks before study or inability to replace.
- Medical conditions requiring drugs with a narrow therapeutic window metabolized by CYP3A without possible dose adjustment.
- Female participants who are lactating or nursing.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
K
Kristina Fanucci, MD, MHS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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