Low Dose Capecitabine for Breast Cancer

Overseen By Katia Khoury, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe hepatic, Renal 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: 12

Duration: 12 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on therapeutic anticoagulation, you should be on a stable dose.

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

Capecitabine (Xeloda) is effective in treating metastatic breast cancer, showing benefits when used alone or with other drugs like docetaxel, especially in patients who have not responded to other treatments. It is well-tolerated and can improve quality of life compared to traditional chemotherapy. ^{1 2 3 4 5}

Is low dose Capecitabine safe for humans?

Capecitabine (also known as Xeloda) is generally considered safe for humans, with common side effects including hand-foot syndrome (redness and swelling of the hands and feet), stomatitis (inflammation of the mouth), and diarrhea. It is an oral medication that allows for quick adjustments in dosage to manage these side effects effectively. ^{4 6 7 8 9}

How does the drug Capecitabine differ from other treatments for breast cancer?

Capecitabine (Xeloda) is unique because it is an oral medication that is selectively activated in tumors to produce 5-fluorouracil (5-FU), a cancer-fighting agent, directly at the tumor site. This drug is particularly beneficial for patients who have not responded to other treatments like anthracyclines and taxoids, and it offers the convenience of oral administration compared to traditional intravenous chemotherapy. ^{1 2 8 10 11}

What is the purpose of this trial?

This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.

Research Team

Katia Khoury, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

This trial is for patients aged ≥60 or frail at any age with advanced breast cancer who have progressed after one treatment line. They must have adequate organ function, HER2 negative status, and either hormone receptor positive or triple-negative breast cancer. Exclusions include HER2 positive cancer, untreated spinal cord compression, prior capecitabine use in metastatic setting, non-measurable disease only, severe liver/renal failure, inability to swallow pills or recent major surgery.

Inclusion Criteria

Patients must be able to provide signed informed consent.

Your bilirubin levels in the blood are not too high. If you have Gilbert disease, your bilirubin levels should be within a certain range.

Your blood clotting tests should be within a certain range if you are not taking blood thinning medication.

Exclusion Criteria

My cancer cannot be measured by standard tests.

I have been treated with Capecitabine for cancer that has spread.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low dose capecitabine (1000 mg daily) for advanced breast cancer

12 weeks

Evaluations every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Capecitabine

Trial Overview The study tests a low dose of the Capecitabine pill (1000 mg daily) on older or frail patients with advanced breast cancer to see if it's effective and safer than other treatments. It's a phase II single-arm trial where all participants receive the same intervention without comparison groups.

Participant Groups

Group I: Low dose capecitabine (Xeloda) Experimental Treatment 1 Intervention

1000 mg capecitabine daily by mouth.

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?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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]

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]

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]

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]

Home-based therapy with oral capecitabine offers significant advantages over traditional intravenous chemotherapy, including improved quality of life for patients and cost savings in the treatment of metastatic colorectal cancer.

Capecitabine has been shown to extend survival in patients with previously treated metastatic breast cancer when used in combination with docetaxel, highlighting its effectiveness and cost-efficiency in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of capecitabine (Xeloda) for cancer nursing practice. Gerbrecht, BM., Kangas, T.[2015]

Capecitabine, an oral medication, showed at least equivalent efficacy to intravenous 5-FU plus leucovorin in treating metastatic colorectal cancer, with an overall response rate of 18.9% compared to 15.0% for 5-FU/LV among 602 patients.

Capecitabine had a more favorable safety profile, resulting in significantly lower rates of stomatitis and neutropenia, while being associated with a higher incidence of hand-foot syndrome, making it a convenient and effective alternative to traditional IV treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. Van Cutsem, E., Twelves, C., Cassidy, J., et al.[2022]

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 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 (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]

The combination of low-dose capecitabine and docetaxel as first-line therapy for anthracycline-pretreated metastatic breast cancer resulted in a 42% response rate and a median overall survival of 23 months among 45 patients studied.

This regimen was well tolerated, with only 11% of patients experiencing grade 3 neutropenia and 7% experiencing grade 3 hand-foot syndrome, suggesting that lower doses of capecitabine may offer a better safety profile while maintaining efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose capecitabine plus docetaxel as first-line therapy for metastatic breast cancer: phase II results. Michalaki, V., Gennatas, S., Gennatas, K.[2018]

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]

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

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

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

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

4. Greece pubmed.ncbi.nlm.nih.gov

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

5. Scotland pubmed.ncbi.nlm.nih.gov

Implications of capecitabine (Xeloda) for cancer nursing practice. [2015]

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

Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. [2022]

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

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

8. Japan pubmed.ncbi.nlm.nih.gov

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

9. Scotland pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Low-dose capecitabine plus docetaxel as first-line therapy for metastatic breast cancer: phase II results. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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