Capecitabine + Cemiplimab for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Immunosuppressants, PD-1 inhibitors

Disqualifiers: Brain metastasis, Autoimmune disorders, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for individuals with HR+ metastatic breast cancer, where the cancer responds to hormones and has spread to other body parts. Researchers aim to determine if combining capecitabine (a chemotherapy pill) with cemiplimab (a drug that boosts the immune system to fight cancer) is safe and effective. The trial includes two groups with different doses of capecitabine to identify the most effective dose. Individuals with HR+ metastatic breast cancer who have not received chemotherapy for this condition and have manageable health issues might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop any herbal or natural remedies that affect the immune system before starting cemiplimab. If you are on immunosuppressive medications, you need to stop them 14 days before the first dose of cemiplimab, with some exceptions for certain types of steroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of capecitabine and cemiplimab is generally safe. In earlier studies, most patients tolerated the treatment well, with no unexpected side effects or serious issues preventing doctors from increasing the dose. Although this treatment remains under investigation, early findings suggest it is safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Capecitabine and Cemiplimab for breast cancer because they bring a fresh approach to treatment. Capecitabine is a chemotherapy drug that disrupts cancer cell growth, while Cemiplimab is an immunotherapy that helps the immune system attack cancer cells more effectively. This combination aims to enhance the body's natural defenses against cancer, offering a potentially more powerful and targeted attack compared to standard chemotherapy alone. Unlike traditional options that mainly focus on directly killing cancer cells, this treatment leverages the body's immune response, potentially leading to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?

Research suggests that combining capecitabine and cemiplimab may help manage hormone-receptor-positive metastatic breast cancer. Participants in this trial will receive one of two dose levels of this combination. Capecitabine, a common breast cancer treatment, is effective and typically causes few side effects, such as hair loss. Studies have shown that adding cemiplimab to capecitabine is safe and might enhance treatment outcomes. This combination has shown promise in controlling cancer spread. Although more information is needed, early findings indicate potential benefits for patients with this type of breast cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Aixa E Soyano Muller, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This study is for adults with hormone-receptor-positive, HER2-negative metastatic breast cancer. Participants must have a performance status of 0-2, indicating they are fully active or capable of self-care. They should not have used PD-1/PD-L1 inhibitors like cemiplimab before and must be free from certain other treatments and conditions that could affect the trial's safety or results.

Inclusion Criteria

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

I can take care of myself and am up and about more than half of my waking hours.

My breast cancer is noninvasive, hormone-receptor positive, and either locally advanced or metastatic.

Exclusion Criteria

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

Patient is currently pregnant or breast feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral chemotherapy capecitabine in combination with cemiplimab to assess safety and efficacy

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Cemiplimab

Trial Overview The trial tests how safe and effective the combination of capecitabine (oral chemotherapy) and cemiplimab (an immune therapy drug) is in treating metastatic breast cancer. It's an early-phase study where all participants receive both drugs to see if they work better together.

How Is the Trial Designed?

Group I: Dose Level 2 Experimental Treatment 2 Interventions

Cemiplimab 350mg + Capecitabine 1000 mg/m\^2

Group II: Dose Level 1 Experimental Treatment 2 Interventions

Cemiplimab 350mg + Capecitabine 800 mg/m\^2

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in United States as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

In a phase II study involving 115 patients with metastatic breast cancer who had previously received anthracycline treatment, the combination of oral vinorelbine and capecitabine demonstrated a promising objective response rate of 56.5%, with 19.1% achieving a complete response.

The treatment was well tolerated, with only 0.8% of patients experiencing febrile neutropenia, and resulted in a median progression-free survival of 10.5 months and a median overall survival of 17.5 months, indicating both efficacy and safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. Finek, J., Holubec, L., Svoboda, T., et al.[2022]

Oral capecitabine is an effective chemotherapy option for metastatic breast cancer, showing favorable efficacy and safety compared to traditional intravenous treatments like cyclophosphamide/methotrexate/5-fluorouracil and paclitaxel, especially in patients who have progressed after anthracycline treatment.

Capecitabine demonstrates enhanced activity when combined with other agents that increase thymidine phosphorylase levels in tumors, such as paclitaxel and vinorelbine, indicating its potential for use in combination therapies for advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving forward with capecitabine: a glimpse of the future. Biganzoli, L., Martin, M., Twelves, C.[2018]

Capecitabine, an oral chemotherapy drug, has shown improved disease-free and overall survival when combined with docetaxel in advanced breast cancer, leading to further exploration of its combinations with other agents.

The combination of capecitabine with docetaxel and epirubicin (TEX) has demonstrated promising results and manageable toxicity, and is currently being evaluated in phase III trials for advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions with capecitabine combinations in advanced breast cancer. Budman, DR.[2015]

Capecitabine is a well-tolerated treatment for metastatic breast cancer, showing minimal side effects like myelosuppression and hair loss, which makes it a promising option for combination therapies with other anticancer drugs.

Ongoing phase II/III trials are investigating the use of capecitabine in early breast cancer treatment, and preliminary results indicate that it may provide significant benefits when used as part of adjuvant and neoadjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. Fumoleau, P., Cameron, D.[2019]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13082

Phase I trial of capecitabine with cemiplimab in patients ... Conclusions: Our study found that the sequence of cemiplimab in combination with capecitabine had an acceptable safety profile. No unexpected ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-10965

Capecitabine and Cemiplimab for the Treatment of ... Giving cemiplimab with capecitabine may help control hormone positive invasive breast cancer.

3. withpower.com withpower.com/trial/phase-1-breast-neoplasms-8-2021-9dc98

Capecitabine + Cemiplimab for Breast Cancer Capecitabine is a well-tolerated treatment for metastatic breast cancer, showing minimal side effects like myelosuppression and hair loss, which makes it a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12036065/

Efficacy of adjuvant capecitabine in triple-negative breast ... Meta analyses noted that adding capecitabine treatment in TNBC was associated with improved outcomes [[24], [25], [26], [27]]. The meta-analysis ...

5. ctv.veeva.com ctv.veeva.com/study/capecitabine-in-combination-with-cemiplimab-in-patient-with-metastatic-breast-cancer

Capecitabine In Combination With Cemiplimab In Patient With ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4770778/

Efficacy and safety of capecitabine-based first-line ... Capecitabine-based chemotherapy significantly improves ORR and PFS in patients with advanced breast cancer, but has no demonstrable impact on OS.

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05064085?keyword=%22Hormone%20Receptor-Positive%20Breast%22

San Mateo Clinical Trial Capecitabine In Combination With ... 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 ...