15 Participants NeededMy employer runs this trial

Capecitabine for Breast Cancer

DC
Overseen ByDavid Cescon, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University Health Network, Toronto
Must be taking: Aromatase inhibitors, CDK4/6 inhibitors
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug capecitabine can benefit individuals with Stage I-III HR+/HER2-negative breast cancer who still have molecular residual disease despite standard treatment. Participants will take capecitabine pills three times daily for up to a year to assess its effectiveness in preventing cancer recurrence. The trial seeks participants who have completed standard breast cancer treatments but still have detectable cancer cells. This study focuses on improving outcomes for those with molecular residual disease after initial treatment. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that capecitabine is generally well-tolerated by many patients, including those with extensive prior cancer treatments. Most do not experience severe side effects. Common mild effects may include fatigue or slight nausea, while serious problems are rare.

One study found that a lower dose of capecitabine reduced side effect risks without compromising effectiveness. Another study reported minimal issues like low blood cell count or hair loss, which are common with many cancer treatments.

Capecitabine is already FDA-approved for treating other types of breast cancer, indicating its safety and effectiveness for many patients. While all medicines can have side effects, capecitabine's safety record remains generally positive.12345

Why do researchers think this study treatment might be promising for breast cancer?

Capecitabine is unique because it's a chemotherapy pill that can be taken orally, unlike many traditional breast cancer treatments that require intravenous administration. This means it's more convenient for patients, allowing them to take their medication at home without frequent hospital visits. Additionally, it works by interfering with the DNA of cancer cells, blocking their growth, which is a targeted approach that can potentially reduce side effects compared to more generalized chemotherapy options. Researchers are excited about Capecitabine because it offers a promising alternative that could improve the quality of life for patients while effectively treating breast cancer.

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

Studies have shown that capecitabine can improve outcomes for breast cancer patients. For those with HER2-negative breast cancer, taking capecitabine after surgery helps patients remain cancer-free for longer. In one study, three years after treatment, 82.8% of patients who took capecitabine were alive and showed no signs of cancer, compared to 73.9% of those who did not take the drug. Other research has also demonstrated a significant decrease in the risk of cancer returning or spreading. These findings suggest that capecitabine could help patients with certain types of breast cancer live longer without cancer recurrence.36789

Are You a Good Fit for This Trial?

This trial is for people with Stage I-III hormone receptor-positive, HER2-negative breast cancer who have had surgery and standard treatments but still show signs of possible remaining cancer (MRD+).

Inclusion Criteria

I agree to use highly effective birth control during the study.
I am fully active or restricted in physically strenuous activity only.
My kidneys are working well based on recent blood tests.
See 11 more

Exclusion Criteria

I have previously been treated with capecitabine.
My high blood pressure is not controlled with medication.
I have digestive issues that affect how I absorb medications.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with capecitabine, administered orally at a dose of 500 mg 3 times daily for up to 12 months, or until clinical recurrence, discontinuation due to toxicity, or withdrawal of consent

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ctDNA clearance and distant recurrence free survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Capecitabine

Trial Overview

The study tests capecitabine pills taken three times a day for up to one year in patients with MRD after initial treatment. The goal is to see if this extra medicine helps prevent the cancer from coming back.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CapecitabineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Efficacy and safety of capecitabine-based first-line ... - PMC

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

Adjuvant Capecitabine for Breast Cancer after ...

The addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2-negative ...

Randomized Trial of Fixed-Dose Capecitabine Compared ...

Oral capecitabine administered for 14 days followed by a 7-day rest period is effective in metastatic breast cancer but results in significant ...

Adjuvant Capecitabine Improves Survival in Residual ...

At 3 years, 82.8% of capecitabine patients were alive and free from recurrence or second cancer, compared with 73.9% of control patients. At 5 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10436412/

Xeloda in the treatment of metastatic breast cancer

In a phase II trial of 163 paclitaxel-refractory patients with metastatic breast cancer, the overall response rate with Xeloda was 20%, with three complete ...

A comparison of toxicity profiles between the lower and ... - PMC

Capecitabine 1,000 mg/m2 bid × 14 days every 21 days (14/21) has been reported to have similar efficacy but more favorable toxicity profile than the approved ...

Multicenter phase II study of oral capecitabine (Xeloda“) in ...

This study confirms that capecitabine achieves a high tumor control rate in heavily pretreated patients with metastatic breast cancer.

An Observational Study of Xeloda (Capecitabine) in ...

This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or ...

Xeloda - accessdata.fda.gov

The safety of XELODA in combination with docetaxel was evaluated in patients with metastatic breast cancer in Study SO14999 [see Clinical Studies (14.2)].