PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) (NCT07222215) | Clinical Trial Compass
RecruitingPhase 2
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
United States297 participantsStarted 2026-01-16
Plain-language summary
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening.
. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.
. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing capecitabine plus elacestrant against capecitabine alone — given my specific situation, does it matter whether I have an ESR1 mutation or not when it comes to whether this combination might be worth considering?
2Since this is a Phase 2 trial, what does that mean for how much is already known about the safety and effectiveness of combining elacestrant with capecitabine, and what unknowns should I be aware of before deciding?
3The trial is randomized, which means I might be assigned to the capecitabine-alone arm rather than the combination — how would that compare to the standard treatment options I already have available outside this trial?
4Capecitabine is an oral chemotherapy that can have side effects like hand-foot syndrome and fatigue — how do you think I would handle that, and does adding elacestrant bring in additional side effects I should think through?
5Before considering this trial, are there standard treatments like CDK4/6 inhibitors or other endocrine therapies that we haven't tried yet that might be a better first step for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) in ESR1 mutant population
Timeframe: Tumor measurements are repeated every 3 cycles (each cycle is 21 days) for the first 9 cycles. After cycle 9 tumor measurements will be performed every 4 cycles.
2
Progression Free Survival (PFS) in intention to treat (ITT) population
Timeframe: Tumor measurements are repeated every 3 cycles (each cycle is 21 days) for the first 9 cycles. After cycle 9 tumor measurements will be performed every 4 cycles.