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PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)

NCT07222215•Kristina A. Fanucci

View on ClinicalTrials.gov

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)

Detailed Description

This is a Phase II, multi-center, open-label, randomized study comparing a combination of two drugs, capecitabine and elacestrant, to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) Human Epidermal Growth Factor Receptor 2 negative (HER2-) 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. Participants will be randomized into one of two study groups: Arm A Capecitabine and Elacestrant versus Arm B Capecitabine alone. Randomization means a participants is placed into a study group by chance. The U.S. Food and Drug Administration (FDA) has approved capecitabine as a treatment option for advanced estrogen receptor-positive (ER+) Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. The FDA has approved elacestrant for metastatic breast cancer with an ESR1 mutation. Elacestrant is not FDA approved for participants whose cancer does not have ESR1 mutation and it is possible elacestrant may not be as effective or effective at all in participants whose tumors do not have an ESR1 mutation. The FDA has not approved Elacestrant and Capecitabine to be given together. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and electrocardiograms (ECGs). It is expected that about 297 people will take part in this research study. Stemline, a Menarini Group Company, is supporting this research study by providing the study drugs, elacestrant, and funding. This study is also being supported by Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2- negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer.
•ER and HER2 measurements should be performed according to institutional guidelines in a CLIA-approved setting. ER must be ≥ 10% on the most recent biopsy in which receptor testing was performed. Cutoff values for positive/negative HER2 staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines
•Participants must have standard of care testing documenting ESR1 mutation status. In patients without ESR1 mutation, this result must be from within 2 months.
•* qualifying ESR1 mutations: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G
•Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with elacestrant participants \<18 years of age are excluded from this study
•Women must be postmenopausal, which is defined as any of the following:
•* Age ≥ 60 years
•* Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range
•* Premenopausal women who have been on a GnRH agonist for at least three consecutive months prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.
•* Status-post bilateral oophorectomy or total hysterectomy after adequate healing post-surgery
+40 more criteria

Exclusion Criteria

•Participants who have had endocrine and/or biologic therapy \< 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1; alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 toxicity not constituting a safety risk based on investigator's judgment are acceptable). This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.
•Participants who are receiving concurrent therapy with other investigational agents. This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.
•Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term. It is likely that these patients will not benefit from this regimen.
•History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.
•Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness/social situations that would limit compliance with study requirements. Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. This could increase risk of toxicity from treatment and potentially decrease adherence to study protocol.

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

January 16, 2026

Primary Completion Date

December 1, 2029

Completion Date

October 1, 2030

Last Updated

January 22, 2026

Enrollment

297

ESTIMATED participants

Conditions

Estrogen-receptor-positive Breast CancerMetastatic Breast CancerBreast CancerHormone Receptor Positive Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastHER2- Breast CancerESR1 Gene MutationER WildtypeBreast Neoplasms

Interventions

Capecitabine

DRUG

Elacestrant

DRUG

Contacts

Kristina Fanucci, MD, MHS

CONTACT

617-632-3800 Kristina_Fanucci@dfci.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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