Capecitabine for Triple-Negative Breast Cancer

Overseen By Cindy Garcia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must be taking: Capecitabine

Disqualifiers: Metastatic cancer, HIV, Hepatitis, 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: 21

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called capecitabine (also known as Xeloda) for individuals with triple-negative breast cancer. Researchers aim to determine if a blood test (called a liquid biopsy) can predict patient response to this treatment. The study seeks to tailor future treatments to reduce the risk of cancer recurrence. It is suitable for those who have had stage I-III triple-negative breast cancer, completed some chemotherapy, and still have residual disease. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial requires a 4-week period without previous chemotherapy treatment before starting. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that capecitabine is likely to be safe for humans?

Research shows that capecitabine is generally well-tolerated by people with triple-negative breast cancer (TNBC). Studies have found that patients treated with capecitabine often experience longer periods without cancer recurrence, suggesting the treatment is effective and reasonably safe.

For instance, one study showed that capecitabine improved survival rates for TNBC patients. Another study found that after a year of treatment, patients had a longer time without disease recurrence. While these studies are promising, they also highlight capecitabine's safety.

Like any treatment, side effects can occur. However, research indicates that capecitabine is usually well-accepted by patients, meaning it doesn't cause severe problems for most people. It is important to consult a healthcare provider to understand how it might work for individual cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Capecitabine is unique because it offers a targeted approach by converting into its active form within tumor cells, potentially reducing harm to healthy cells. Researchers are excited about capecitabine for triple-negative breast cancer because it can be taken orally, providing a more convenient option compared to intravenous chemotherapy. Additionally, its ability to interfere directly with DNA synthesis in cancer cells could offer a new angle of attack against this aggressive cancer type, which typically has fewer treatment options.

What evidence suggests that capecitabine might be an effective treatment for triple-negative breast cancer?

Research shows that capecitabine effectively treats triple-negative breast cancer (TNBC). Studies have found that patients with TNBC who still have some cancer after initial treatment benefit from taking capecitabine, which increases their chances of survival. One study discovered that patients treated with capecitabine had a much higher chance of being cancer-free five years later. Additionally, adding capecitabine to the usual chemotherapy for early-stage TNBC significantly improved survival rates. Overall, these findings suggest that capecitabine can help improve outcomes for TNBC patients. Participants in this trial will receive capecitabine as part of the study treatment. ^{1 2 4 5 6}

Who Is on the Research Team?

Melinda Telli

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage triple-negative breast cancer who've had some chemo but still have disease present. They must be planning to take capecitabine, have good kidney and liver function, not be pregnant or breastfeeding, and agree to use contraception. People with metastatic cancer, HIV, hepatitis B/C, or recent investigational drug use can't join.

Inclusion Criteria

My side effects from previous cancer treatments are mild, except for hair loss and some nerve pain.

My cancer has not spread to other parts of my body.

I am a woman who can have children and I have a negative pregnancy test.

Exclusion Criteria

I am HIV positive or have active hepatitis B or C.

I have not had surgery to completely remove my cancer.

You have taken any experimental drugs within 4 weeks before the study starts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant capecitabine treatment and are monitored for ctDNA levels

6 months

Every 21 days (in-person)

Follow-up

Participants are monitored for relapse-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine

Trial Overview The study tests if monitoring ctDNA levels in the blood can predict the effectiveness of capecitabine treatment in preventing breast cancer relapse. It involves regular 'liquid biopsies' during treatment to see how ctDNA changes correlate with tumor genetics.

How Is the Trial Designed?

Group I: Capecitabine Experimental Treatment 1 Intervention

1000 mg/m2 administered on Days 1 to 14 of 21-day cycles

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A meta-analysis of seven randomized clinical trials involving 3151 early-stage triple-negative breast cancer (TNBC) patients showed that adding capecitabine to standard chemotherapy significantly improved disease-free survival (DFS) with a hazard ratio of 0.77.

The same analysis indicated a significant increase in overall survival (OS) for patients receiving capecitabine, with a hazard ratio of 0.69, suggesting that capecitabine can enhance treatment outcomes for early-stage TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant addition of capecitabine to early-stage triple-negative breast cancer patients receiving standard chemotherapy: a meta-analysis. Li, Y., Zhou, Y., Mao, F., et al.[2020]

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]

Cisplatin and capecitabine combination therapy showed a response rate of 62.1% in 29 patients with metastatic triple negative breast cancer (TNBC) who had previously progressed after other treatments, indicating its efficacy as a subsequent treatment option.

The therapy was generally well-tolerated, with most side effects being mild to moderate, although some patients experienced significant toxicities such as neutropenia and leukocytopenia, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of cisplatin plus capecitabine for patients with metastatic triple negative breast cancer progressing after anthracycline and taxane treatment]. Li, Q., Xu, B., Li, Q., et al.[2018]

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]

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]

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 maintenance therapy (MT) significantly prolongs progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) after initial treatment with capecitabine plus docetaxel, with median PFS of 10.1 months for the MT group compared to 6.7 months for the non-MT group.

The safety profile of capecitabine MT is favorable, as adverse events such as hematologic toxicity and gastrointestinal issues were not significantly different between the maintenance and non-maintenance treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine maintenance therapy for XT chemotherapy-sensitive patients with metastatic triple-negative breast cancer. Liang, X., Di, L., Song, G., et al.[2020]

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 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]

Capecitabine is an effective oral prodrug for treating triple-negative breast cancer (TNBC), converting to 5-fluorouracil preferentially in tumors, and is generally well tolerated with minimal side effects.

In a case report of a 34-year-old woman, capecitabine caused rare neurotoxicity (leukoencephalopathy), which resolved after discontinuation of the drug, highlighting the importance of early detection and prompt management of such side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine-induced leukoencephalopathy in a patient with triple-negative breast cancer: A case report and review of the literature. Liu, L., Brown, EN., Abu-Shahin, FI.[2022]

Capecitabine maintenance therapy significantly improved progression-free survival (PFS) and overall survival (OS) in patients with non-basal-like metastatic triple-negative breast cancer (mTNBC), with median PFS of 7.3 months compared to 5.7 months in the observation group.

Cytokeratin 5/6 (CK5/6) and epidermal growth factor receptor (EGFR) status were identified as important prognostic biomarkers, indicating that patients with non-basal-like TNBC could particularly benefit from capecitabine maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prognostic and predictive significance of cytokeratin 5/6 and epidermal growth factor receptor in metastatic triple-negative breast cancer treated with maintenance capecitabine. Zhu, Y., Li, K., Zhang, J., et al.[2022]

Citations

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

Efficacy of adjuvant capecitabine in triple-negative breast ... Adjuvant capecitabine therapy significantly improved the prognosis of patients with TNBC who had residual disease after NAT.

2. esmoopen.com esmoopen.com/article/S2059-7029(25)01437-1/fulltext

Adjuvant capecitabine in patients with triple-negative ... In terms of outcomes, among patients with TNBC in CREATE-X, the 5-year DFS rate was significantly higher in patients treated with capecitabine ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526820924003690/pdf

Effectiveness of Adjuvant Capecitabine in Triple-Negative ... 1, 2, 3 Patients with TNBC achieving pCR after NAC have markedly better 5-year survival rates (∼90%) than those with residual disease (∼50%), highlighting the ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1612645

Adjuvant Capecitabine for Breast Cancer after ... Our trial showed that adjuvant capecitabine therapy prolonged disease-free survival and overall survival among patients with breast cancer who ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9300946/

Efficacy and Safety of Capecitabine for Triple-Negative ... The addition of capecitabine to early-stage TNBC patients receiving standard adjuvant chemotherapy showed significant DFS and OS improvement with tolerable ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e12530

Tolerance and safety of adjuvant metronomic capecitabine ... SYSUCC-001 study presented in ASCO 2020 reported an increased disease-free survival after one year of metronomic capecitabine in operable TNBC ...