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

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug combination Capecitabine and Cemiplimab for breast cancer?

Research shows that Capecitabine, when used with other cancer drugs, is effective in treating breast cancer, improving survival rates and response rates. Capecitabine is well-tolerated and can be combined with other treatments to enhance its effectiveness, suggesting potential benefits when combined with Cemiplimab. ^{1 2 3 4 5}

What makes the drug combination of Capecitabine and Cemiplimab unique for breast cancer treatment?

The combination of Capecitabine and Cemiplimab is unique because Capecitabine is an oral drug that is well-tolerated and can be combined with other therapies, while Cemiplimab is an immune checkpoint inhibitor that helps the immune system attack cancer cells. This combination may offer a novel approach by leveraging both chemotherapy and immunotherapy to treat breast cancer. ^{1 3 6 7 8}

Research Team

Aixa E Soyano Muller, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Moving forward with capecitabine: a glimpse of the future. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing the management of HER2-negative metastatic breast cancer with capecitabine (Xeloda). [2019]

5. India pubmed.ncbi.nlm.nih.gov

Xeloda and Taxotere: a review of the development of the combination for use in metastatic breast cancer. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine/capecitabine in patients with metastatic breast cancer pretreated with anthracyclines and taxanes. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Epirubicin Plus Cyclophosphamide Followed by Docetaxel Versus Epirubicin Plus Docetaxel Followed by Capecitabine As Adjuvant Therapy for Node-Positive Early Breast Cancer: Results From the GEICAM/2003-10 Study. [2022]