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Hormone Receptor-positive Breast CancerPhase 1NCT05064085

Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer

A Phase 1 study testing Cemiplimab and Capecitabine in people with Hormone Receptor-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hormone Receptor-positive Breast Cancer
What is being tested?
Cemiplimab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
12 Oct 2021to 13 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide a written informed consent and any locally required authorization prior to performing any protocol-related procedures,including screening evaluations.
  • Female or male, age 18 years or older
  • Eastern Cooperative Oncology Group (EGOG) performance status 0 through 2
  • Pathologic confirmation of noninvasive breast cancer that is Hormone-receptor positive (HR+) (ER [estrogen-receptor] and/or PR [progesterone-receptor] >/= 1%, locally advanced, or metastatic disease.
  • Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2) negative defined as 0 or 1+ by immunohistochemistry (IHC) or with an in situ hybridization (ISH) ratio (HER2 gene copy/chromosome 17) < 2 or as defined by ASCO/CAP guidelines
  • Measurable or non-measurable disease
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  • Any line of prior endocrine therapy in the unresectable and /or metastatic setting
  • Adequate organ and marrow function as defined in protocol
  • Participants must be willing and able to comply with the protocol for the duration of the study. This compliance includes undergoing treatment, scheduled visits, and examinations, including follow-up.
  • If taking herbal or natural remedies that may have immune modulatory effects, participants must be willing to discontinue them before first dose of cemiplimab
  • Body weight greater than 30 kg

Who cannot join

  • Participation in another clinical study with an investigational product during the last 4 weeks
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Received prior systemic cytotoxic chemotherapy for unresectable and/or metastatic disease. Patients who received 1 cycle or fewer at least 3 months prior to enrollment, which was discontinued for reasons other than disease progression, may be enrolled at the discretion of the PI.
  • Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab.
  • Nontreated brain metastasis. Treated brain metastasis is allowed if patients are stable and off steroids for at least 2 months prior to enrollment.
  • Leptomeningeal disease.
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  • History of another primary malignancy, except for malignancy treated with curative intent; no known active disease for ≥2 years; adequately treated non-melanoma skin cancer or lentigo maligna (without evidence of disease); or adequately treated carcinoma in situ without evidence of disease (eg, cervical cancer in situ).
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of cemiplimab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid; or steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, pneumonitis etc]). The following are exceptions to this criterion: (a) Patients with vitiligo or alopecia. (b) Patients with hypothyroidism (eg, following Hashimoto syndrome) who are stable on hormone replacement. (c) Any chronic skin condition that does not require systemic therapy. (d) Patients without active disease in the last 5 years may be included but only after consultation with the study physician. (e) Patients with celiac disease controlled by diet alone.
  • Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) prior to the first dose of cemiplimab or (b) associated with immune-mediated AEs that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent
  • Prior treatment with idelalisib. The decision to treat with cemiplimab tumor types for which cemiplimab and/or other anti-PD-1/ PD-L1 agents have demonstrated efficacy, such as advanced CSCC, merits an individualized risk:benefit assessment by the treating physician in discussion with the patient, in the event that a patient had prior exposure to idelalisib.
  • History of primary immunodeficiency.
  • History of allogeneic organ transplant.
  • Known allergy or history of hypersensitivity to cemiplimab or any excipient.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
  • Known active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for the hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Note: This is applied only to patients with a known infection. Screening tests for TB, hepatitis B and C, or HIV are not required.
  • Receipt of live attenuated vaccination within 30 days prior to receiving cemiplimab. Note: Patients, if enrolled, should not receive a live vaccine while receiving cemiplimab and up to 30 days after the last dose of cemiplimab.
  • Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study treatment or interpretation of patient safety or study results.
  • Patients with uncontrolled seizures.
  • Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of investigational product.
  • Patient is currently pregnant or breast feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I Trial of Capecitabine in Combination With Cemiplimab in Patients With Hormone Receptor Positive Metastatic Breast Cancer

This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.

Keywords
Breast Cancer, HR+
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called Libtayo

    Participants will be given Cemiplimab 350 mg IV day 1 every 21 days

  • CapecitabineDrug

    Also called Xeloda

    Participants will take Capecitabine at 2 dose levels: 800 mg/m^2 and 1000 mg/m^2 by mouth twice daily 14 days on, 7 days off starting on day 3 every 21 days.

Study groups in NCT05064085
Study groupRoleWhat they receive
Dose Level 1ExperimentalCemiplimab 350mg + Capecitabine 800 mg/m^2
Receives: Drug: Cemiplimab; Drug: Capecitabine
Dose Level 2ExperimentalCemiplimab 350mg + Capecitabine 1000 mg/m^2
Receives: Drug: Cemiplimab; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D)

    Recommended Phase 2 dose of Capecitabine combined with Cemiplimab will be determined by testing 2 dose levels. RP2D reflects the highest dose that did not cause Dose Limiting Toxicity (DLT)

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Objective response rate is defined as the sum of complete response and partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1.

    Measured: Up to 24 months

  2. Clinical Benefit Rate (CBR)

    Clinical benefit rate is defined as the sum of complete response, partial response, and stable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1.

    Measured: Up to 24 months

  3. Progression Free Survival (PFS)

    Progression free survival is defined as the time from start of treatment to documented disease progression or death due to any cause

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start12 Oct 2021
  3. Primary completion9 Sep 2024
  4. Study completion13 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064085
Sponsor's protocol ID
MCC-20902
Other IDs
R2810-ONC-20109
Status last verified
Jun 2026
First submitted
29 Sep 2021
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aixa Elena Soyano Muller et al. Phase I trial of capecitabine with cemiplimab in patients with hormone receptor-positive metastatic breast cancer.. JCO 43, e13082-e13082(2025). DOI:10.1200/JCO.2025.43.16_suppl.e13082

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cemiplimab and Capecitabine in people with Hormone Receptor-positive Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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