Capecitabine for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Antiestrogens

Disqualifiers: Pregnancy, Brain metastasis, Heart failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

35 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on antiestrogen treatments like aromatase inhibitors or selective estrogen modulators, you can continue them. Denosumab and zoledronic acid are also allowed as adjunct therapies.

What data supports the effectiveness of the drug Capecitabine (Xeloda) for breast cancer?

Research shows that Capecitabine (Xeloda) is effective in treating metastatic breast cancer, especially in patients who have not responded to other treatments. Studies indicate that it can improve survival rates and is well-tolerated, with common side effects being manageable. ^{1 2 3 4 5}

Is capecitabine (Xeloda) safe for humans?

Capecitabine (Xeloda) is generally considered safe for humans, with common side effects including hand-foot syndrome (redness and swelling of the hands and feet), diarrhea, and mouth sores. It is well-tolerated, and side effects can often be managed by adjusting the dose. ^{1 2 6 7 8}

How is the drug Capecitabine (Xeloda) unique in treating breast cancer?

Capecitabine (Xeloda) is unique because it is an oral medication that is selectively activated at the tumor site, producing the active drug 5-fluorouracil (5-FU) directly where it's needed. This drug is particularly beneficial for patients with metastatic breast cancer who have not responded to other treatments, and it is known for being well-tolerated with fewer side effects like hair loss and low blood cell counts. ^{1 2 3 5 9}

What is the purpose of this trial?

This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.

Research Team

Lida Mina

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with a type of breast cancer that responds to hormones (ER positive) and lacks the HER2 protein, which has spread beyond its original location. Participants must not have been treated with capecitabine before.

Inclusion Criteria

ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)

My breast cancer is ER+ and HER2-, as confirmed by tests.

Provide written informed consent

Exclusion Criteria

History of severe hypersensitivity reactions to fluorouracil or capecitabine

I have not had major surgery in the last 3 weeks.

I have not had radiation therapy in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Standard Phase

Patients receive standard dose of capecitabine orally twice daily on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

6 weeks

2 visits (in-person)

Adaptive Phase

Patients receive 50% reduced dose of capecitabine orally twice daily on days 1-14 of each cycle. Dose adjustments are made based on disease burden assessed via CT or blood samples. Cycles repeat every 21 days.

Variable, up to 5 years

Every cycle (in-person), CT every other cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes blood sample collection, CT or MRI, and bone scan if indicated.

Up to 3 years

Every 3 months

Treatment Details

Interventions

• Capecitabine

Trial Overview The study tests how well capecitabine, an antimetabolite medication that transforms into a substance killing tumor cells, works in controlling metastatic ER positive, HER2 negative breast cancer by adjusting doses based on tumor response.

Participant Groups

Group I: Treatment (capecitabine) Experimental Treatment 6 Interventions

See Detailed Description.

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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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]

In a study of 42 patients with advanced breast and colorectal cancer, capecitabine showed a partial response rate of 29.16% for breast cancer and 11.76% for colorectal cancer, indicating its potential efficacy in these pretreated patients.

Capecitabine was well tolerated with low toxicity levels, as most adverse reactions were mild, although 7.14% of patients experienced grade 3 hand-foot syndrome, and hypertriglyceridemia was noted in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine (Xeloda) as monotherapy in advanced breast and colorectal cancer: effectiveness and side-effects. Stathopoulos, GP., Koutantos, J., Lazaki, H., et al.[2022]

Xeloda (capecitabine) is an effective oral treatment for metastatic breast cancer patients who have not responded to anthracycline and paclitaxel chemotherapy, showing a 20% overall response rate in a phase II trial with 163 patients and a median survival of 12.8 months.

Xeloda is well tolerated, with common side effects including hand-foot syndrome and nausea, and it has demonstrated higher response rates compared to paclitaxel and cyclophosphamide/methotrexate/5-FU in additional studies, making it a valuable option for patients with limited treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Xeloda in the treatment of metastatic breast cancer. Blum, JL.[2017]

Capecitabine is an oral pro-drug of fluorouracil that has been approved by the FDA as a first-line treatment for metastatic colorectal cancer and for use in metastatic breast cancer patients who are resistant to other treatments.

The drug has shown improved tolerability and comparable efficacy to intravenous fluorouracil, making it a convenient and effective option for treating various carcinomas, including prostate, pancreatic, renal cell, and ovarian cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the oral fluorouracil pro-drug capecitabine in cancer treatment: a review. Koukourakis, GV., Kouloulias, V., Koukourakis, MJ., et al.[2023]

Capecitabine (Xeloda) is an effective treatment for advanced/metastatic breast cancer, showing a response rate of 20% in a phase 2 trial with a median survival time of 452 days for patients who were resistant to previous therapies.

The most common side effects reported were hand-foot syndrome and various blood-related issues, indicating that while Capecitabine can be beneficial, it also carries a risk of significant adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological and clinical properties of Xeloda (Capecitabine), a new oral active derivative of fluoropyrimidine. Nishida, M.[2018]

Capecitabine is the first oral chemotherapy approved in Canada for treating metastatic breast and colorectal cancer, allowing for home-based administration which requires careful side-effect management by oncology nurses.

While capecitabine is generally well tolerated, it can cause hand-foot syndrome, the most common dose-limiting side effect, necessitating proactive management strategies and patient education to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Canadian experience with capecitabine: partnering with patients to optimize therapy. Gerbrecht, BM.[2019]

Capecitabine (Xeloda) is an oral chemotherapy that delivers 5-FU directly to tumors, offering superior response rates and equivalent survival outcomes compared to intravenous 5-FU in first-line metastatic colorectal cancer (MCRC).

Capecitabine has a favorable safety profile, with manageable side effects like hand-foot syndrome and diarrhea, allowing for prompt dose adjustments without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of and clinical experience with capecitabine (Xeloda) in the treatment of solid tumours. Sternberg, CN., Reichardt, P., Holland, M.[2015]

Capecitabine, a chemotherapy drug, can cause adverse effects such as hand-foot syndrome (HFS) and oral hyperpigmentation, particularly in females and individuals with darker skin tones, as highlighted in a case report.

The study emphasizes the need for better recognition and diagnosis of oral hyperpigmentation associated with capecitabine, as its underlying mechanism remains unclear and is not well-documented in existing literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine-induced oral mucosal hyperpigmentation associated with hand-foot syndrome - A literature review. Nascimento, ADAD., Porto, DM., Vidal, AKL.[2023]

A retrospective study of 12 patients with severe renal impairment (GFR <30 mL/min) showed that capecitabine can be safely administered with close monitoring and dose adjustments, despite previous contraindications from the manufacturer based on a small Phase II trial.

Most patients experienced only mild to moderate adverse effects, and some showed a positive response to treatment, indicating that capecitabine may still be effective in this population when managed carefully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective observational study on the use of capecitabine in patients with severe renal impairment (GFR Jhaveri, KD., Flombaum, C., Shah, M., 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. Greece pubmed.ncbi.nlm.nih.gov

Capecitabine (Xeloda) as monotherapy in advanced breast and colorectal cancer: effectiveness and side-effects. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Xeloda in the treatment of metastatic breast cancer. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of the oral fluorouracil pro-drug capecitabine in cancer treatment: a review. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Pharmacological and clinical properties of Xeloda (Capecitabine), a new oral active derivative of fluoropyrimidine. [2018]

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

Current Canadian experience with capecitabine: partnering with patients to optimize therapy. [2019]

7. Scotland pubmed.ncbi.nlm.nih.gov

Development of and clinical experience with capecitabine (Xeloda) in the treatment of solid tumours. [2015]

8. Spain pubmed.ncbi.nlm.nih.gov

Capecitabine-induced oral mucosal hyperpigmentation associated with hand-foot syndrome - A literature review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A retrospective observational study on the use of capecitabine in patients with severe renal impairment (GFR [2022]