PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Kristina A. Fanucci
Study ID
NCT07222215
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    A fluoropyrimidine carbamate, tablet taken orally, per standard of care.
  • Elacestrant — DRUG
    A selective estrogen receptor degrader, tablet taken orally, per standard of care

Study Details

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)

Key Dates

Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Dec 1, 2029
Completion
Oct 1, 2030

Study Design

Enrollment
297 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Capecitabine + Elacestrant
    Participants will be randomized 1:1, enrolled, and stratified based on the receipt of one or two prior lines of endocrine therapy in the metastatic setting, presence or absence of visceral disease, presence or absence of ESR1 mutation, and presence or absence of p53 mutation. * Baseline visit with assessments * Imaging every 9 weeks for 27 weeks, then every 12 weeks * Cycle 1 through End of Treatment (21-day cycles): * Days 1 - 14: Predetermined dose of Capecitabine 2x daily for 14 days followed by 7 days off * Days 1 - 21: Predetermined dose of Elacestrant 1x daily * Follow up: every 6 months after end of treatment
  • Experimental: Arm B: Capecitabine Monotherapy
    Participants will be randomized 1:1, enrolled, and stratified based on the receipt of one or two prior lines of endocrine therapy in the metastatic setting, presence or absence of visceral disease, presence or absence of ESR1 mutation, and presence or absence of p53 mutation. * Baseline visit with assessments * Imaging every 9 weeks for 27 weeks, then every 12 weeks * Cycle 1 through End of Treatment (21-day cycles): --Days 1 - 14: Predetermined dose of Capecitabine 2x daily for 14 days followed by 7 days off * Follow up: every 6 months after end of treatment
  • Experimental: Optional switch after progression on Arm B Capecitabine monotherapy: Elacestrant Monotherapy
    For Arm B participants with ESR1 mutation, at the time of progression on Capecitabine participants have the option to continue on trial and switch to single agent Elacestrant monotherapy. -Imaging every 9 weeks for 27 weeks, then every 12 weeks Through End of Treatment (21-day cycles): --Days 1 - 21: Predetermined dose of Elacestrant 1x daily -Follow up: every 6 months after end of treatment

Primary Outcome Measure

Progression Free Survival (PFS) in ESR1 mutant population [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kristina Fanucci, MD
[email protected]
617-632-3800
Kristina Fanucci, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MA

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