CLINICAL TRIAL

Capecitabine for Breast Cancer

Metastatic
Stage I
Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether a combination of drugs may help treat breast cancer that has spread to the brain.

See full description

About the trial for Breast Cancer

Eligible Conditions
Leptomeningeal Disease (LMD) · Metastatic Breast Cancer · Breast Neoplasms

Treatment Groups

This trial involves 2 different treatments. Capecitabine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Capecitabine
DRUG
Tucatinib
DRUG
Trastuzumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Tucatinib
FDA approved
Trastuzumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Evidence of leptomeningeal disease (LMD) as diagnosed by a) presence of malignant cells in CSF (+CSF cytology) and/or b) Magnetic Resonance Imaging (MRI) evidence of LMD, plus clinical signs and/or symptoms. NOTE: Measurable extra-CNS disease is not required. Note: Patients who have MRI evidence of focal LMD with negative cytology and no symptoms are not eligible for enrollment.
Karnofsky Performance Status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3
Contrast-enhanced MRI Note: If patient has implants in place that are MRI incompatible, these must be removed prior to enrollment.
Placement of an Ommaya reservoir (ventricular access device). Note: This is mandatory for the first 15 patients enrolled onto the protocol (first stage). In the second stage, this is strongly recommended per protocol. If a patient cannot or chooses not to undergo Ommaya placement in the second stage, the patient will be allowed to enroll.
Evaluation by medical oncologist at baseline and at every cycle (required)
Men and women, age ≥18 years at time of consent
Histologically proven metastatic infiltrating carcinoma of the breast that is HER2 positive - Immunohistochemistry (IHC) 3+ and/or Fluorescence in situ hybridization (FISH) ratio >2.0, or average HER2 copy number >6.0 signals per cell or per current ASCO-CAP (American Society of Clinical Oncology - College of American Pathologists) or NCCN (National Comprehensive Cancer Network) guidelines. (NOTE: HER2 testing may be performed on primary and/or metastatic site; Any estrogen and progesterone [ER/PR] status is allowed.)
Evaluation by neurologist/neuro-oncologist at baseline and at every cycle (strongly recommended); if this is not possible at a site, a medical oncologist may per perform the protocol specified evaluations at each visit.
Patients who are on steroids due to CNS disease or LMD diagnosis should be on a stable dose for at least 5 days prior to registration.
>14 days since last dose of any previous endocrine therapy, chemotherapy, trastuzumab or other antibody-based therapy. NOTE: If patients have been previously receiving trastuzumab on a weekly basis (at a dose of 2mg/kg), only a 7 day washout will be required.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Capecitabine will improve 1 primary outcome and 8 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Baseline to 12 weeks.

Progression free survival
BASELINE TO 12 WEEKS
From the start of treatment to 12 weeks
BASELINE TO 12 WEEKS
Symptom Burden
BEGINNING AT BASELINE AND EVERY 21 DAYS UNTIL THE END OF STUDY UP TO THREE YEARS
The M.D. Anderson Symptom Inventory Brain Tumor (MDASI -BT) module questionnaire will collect data at each study time point and evaluate changes of symptom burden.
BEGINNING AT BASELINE AND EVERY 21 DAYS UNTIL THE END OF STUDY UP TO THREE YEARS
Quality of Life Assessment
BEGINNING AT BASELINE AND EVERY 42 DAYS UNTIL THE END OF STUDY UP TO THREE YEARS
The Linear Analog Scale Assessment Quality of Life will be used to evaluate changes in the quality of life at restaging visits.
BEGINNING AT BASELINE AND EVERY 42 DAYS UNTIL THE END OF STUDY UP TO THREE YEARS
Overall survival
FROM DATE OF STUDY ENROLLMENT UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER COMES FIRST, ASSESSED UP TO 3 YEARS
Length of subject survival after starting study treatment. A Gehan-like trial design with an interim futility analysis will be used.
FROM DATE OF STUDY ENROLLMENT UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER COMES FIRST, ASSESSED UP TO 3 YEARS
Number of adverse events
BASELINE UP TO 3 YEARS OR UNTIL DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY OR DEATH.
Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Subjects who receive at least one dose of the drug combination will be evaluable for toxicity from the time of the first dose.
BASELINE UP TO 3 YEARS OR UNTIL DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY OR DEATH.
Objective response in extra-CNS disease
BASELINE UP TO 3 YEARS
Data from subjects who have received at least one cycle of therapy and disease re-evaluation for extra-CNS tumors by imaging, cytopathology, and clinical evaluation will be accumulated until disease progression. Extra-CNS response will be classified per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
BASELINE UP TO 3 YEARS
See More

Who is running the study

Principal Investigator
E. S.
Prof. Erica Stringer-Reasor, Assistant Professor
University of Alabama at Birmingham

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for breast cancer?

Results from a recent clinical trial found that most breast cancer patients receive some form of adjuvant treatment, including antiestrogenic medications, chemotherapy, and radiation therapy.

Anonymous Patient Answer

How many people get breast cancer a year in the United States?

Breast cancer is one the most devastating types of human cancer. The National Committee of Cancer in the USA (NCCN) publishes estimates of new cancer cases per year in the United States. There are over two dozen methods of calculating new cancer cases. The most widely reported methods of estimating new cancer cases are by using incidence rates, and by using statistics of mortality. One of the most widely used mortality statistics is the number of people dying from breast cancer per year, per 100,000 U.S. women from age 20 to 99 years.

Anonymous Patient Answer

What causes breast cancer?

It is possible that in addition to environmental exposures, the genetic risk of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is also affected by factors such as nutritional needs and life style, as well as the hormonal influences of pregnancy on the breast tissue. Furthermore, it is well known from case studies that breast cancer can cause breast cancer in genetically related women to whom a risk-carrying BRCA mutation is present.\n

Anonymous Patient Answer

What are the signs of breast cancer?

The majority of survivors (77.2%) report at least one sign at the time of diagnosis. In those survivors who reported one sign only, the signs were mostly specific: pain/tenderness in the affected or axillary lymph nodes (73.6%), feeling swollen (69%), and a lump in the breast (61%). In those survivors who reported more than one sign, the signs were nonspecific: pain/tenderness in the affected or axillary lymph nodes (60.7%), feeling swollen (48.9%), and a lump in the breast (26.1%).

Anonymous Patient Answer

What is breast cancer?

Breast cancer is a debilitating disease that affects both men and women. There are a large number of factors associated with breast cancer that may have arisen in response to early use of human and animal breast cancer in the prevention of disease.

Anonymous Patient Answer

Can breast cancer be cured?

There is significant variation in cure rates within individual U.S. states; the state in which a woman lives is a stronger predictor of a woman's chances of having early cancer than specific treatment approaches. There is little state-level variation in cure rates for stage 4 breast cancer among women 40-80 years old; if women are not uninsured, this may be due to early detection. The cure rates reported by states for stage 4 breast cancer among women 60-80 years old do not appear to be consistent with current evidence; states should review this information in consultation with treatment centers.

Anonymous Patient Answer

What are the chances of developing breast cancer?

The chance of developing [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) at any age is approximately 1 in 9, and that of invasive breast cancer is approximately 1 in 16. The occurrence of breast cancer increases almost as much as the length of life, but in terms of years lived, those with a cancer diagnosis live on average more than 12 years longer than women without the disease. The mean age at diagnosis of breast cancer is approximately 70 years. Over half of women diagnosed with breast cancer are diagnosed after 65, and by age 90, more than 70 percent of these women have had cancer.

Anonymous Patient Answer

What does capecitabine usually treat?

This retrospective review demonstrates that capecitabine typically has a favorable safety profile in the treatment of metastatic breast cancer, although the incidence of side effects is higher than in previous reports. The most common side effects were diarrhea (7/8 patients) and nausea (5/8 patients).

Anonymous Patient Answer

Has capecitabine proven to be more effective than a placebo?

Data from a recent study, no significant difference in pCR was seen between CTX and PTX at a dose of 1200 mg/m(2) given 4-weeks apart. Because many patients experienced grade 3 or 4 diarrhea and neutropenia at this dose, the dose of CTX was changed. However, the rate of pCR was similar to that in the placebo group.

Anonymous Patient Answer

What is the primary cause of breast cancer?

According to the results of a questionnaire-gathering survey of women diagnosed as breast cancer, the primary cause is unknown or unknown; the primary cause was more likely to be attributed to breast cancer progression.

Anonymous Patient Answer

Does breast cancer run in families?

Results from a recent clinical trial in the Saudi Arabian population suggests that breast cancer in a family is associated with a higher risk of breast cancer in the family members if the disease is already present and if the family history of breast cancer is positive.

Anonymous Patient Answer

Is capecitabine typically used in combination with any other treatments?

We found several studies that included capecitabine in combination with radiotherapy (IRL-0233) or cytotoxic chemotherapy. In a recent study, findings suggest that capecitabine is frequently administered in combination with other treatments.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Breast Cancer by sharing your contact details with the study coordinator.