A Phase 2 interventional study of Radiation Therapy and Capecitabine in Breast Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy.
The safety of this study treatment will also be studied.
The Study Treatment:
Radiation therapy and capecitabine are both designed to interfere with the growth of cancer cells.
Study Therapy:
If you are found to be eligible to take part in this study, you will receive radiation therapy once or twice a day, 5 days a week, for about 5 -7 weeks. The schedule and number of weeks will be the doctor's decision based on the type of breast cancer.
The radiation treatments will take about 15-30 minutes each time.
You will take the Capecitabine pills by mouth every day during the 5-7 weeks that you receive radiation therapy. The pills should be taken 2 times a day, about 12 hours apart, 30 minutes after eating food. On the radiation therapy days, you will take capecitabine about 2 hours before the radiation therapy.
You will be given a pill diary in which you should record what time you take each dose of capecitabine.
Study Visits:
Once a week while you are receiving study treatment, you will have a physical exam.
Length of Study:
You may remain on study treatment for up to 7 weeks. You will be taken off study treatment early if the disease gets worse or intolerable side effects occur.
Based on the status of the cancer, if you become eligible to have surgery after radiation, you will be referred to a surgeon to discuss that option.
Follow-Up Visits:
At Month 3 after finishing radiation therapy (or surgery, if applicable), you will have a positron emission tomography / computed tomography (PET/CT) scan or ultrasound to check the status of the disease.
At Months 9, 17, and 29 after finishing radiation therapy or surgery, you may have a PET/CT scan, ultrasound, and/or routine blood tests if your doctor thinks it is needed. The amount of blood drawn, if any, will be the doctor's decision based on routine care.
This is an investigational study. Capecitabine is commercially available and FDA approved to treat breast cancer that has spread. Radiation therapy is also commonly used to treat breast cancer. The combination of capecitabine and radiation therapy is commonly used to treat rectal cancer.
At this time, it is considered investigational to give the combination of capecitabine and radiation therapy to patients with breast cancer.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 33 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capecitabine 825 mg/m2 twice a day. One of the two daily doses of capecitabine should be taken approximately 2 hours before receiving radiotherapy. The first day of Capecitabine is same day that radiotherapy is started, and last day that Capecitabine is given is last day of radiotherapy. Capecitabine administered only on days patient receives radiation therapy. Radiation therapy dose 50-57 Gy to initial clinical target volume (CTV, gross disease + tissue at risk for micrometastatic disease including margin around gross disease and draining regional lymphatics).
Radiation: Radiation Therapy · Drug: Capecitabine
50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time.
Also known as: RT, Radiotherapy
During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy.
Also known as: Xeloda
Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.
The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.
Time frame: Participants were monitored from 2009 to 2012.
Primary objective is to determine the rate of responses by RECIST criteria in all patients who received treatment that includes pre-operative or palliative concurrent radiation with capecitabine to the breast and at risk or involved regional lymph node basins. The recruitment process was located at MD Anderson Cancer Center between 2009 to 2012.
| Milestone | Single Arm Institution, Open Label, Phase II |
|---|---|
| Started | 33 |
| Completed | 26 |
| Not completed | 7 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Insurance denial | 2 |
The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.
| participants | Single Arm Institution, Open Label, Phase II |
|---|---|
| Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins. | 26 |
Collected over Subjects will be followed ever 3 months (+/- 1 mo) post-treatment times 1, then every 6 months (+/- 1 mo) times 1, then every 12 months (+/- 2 mos) times 2, up to 3 years. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Institution, Open Label, Phase II | 0/26 (0%) | 0/26 (0%) | 18/26 (69.2%) |
| Event | Single Arm Institution, Open Label, Phase II |
|---|---|
| VomittingGeneral disorders | 7/26 |
| Pain: stomachGastrointestinal disorders | 7/26 |
| ThrombusBlood and lymphatic system disorders | 6/26 |
| Hand/foot skin reactionSkin and subcutaneous tissue disorders | 6/26 |
| Pain: skinSkin and subcutaneous tissue disorders | 5/26 |
| Infection with uknown NeutropeniaBlood and lymphatic system disorders | 5/26 |
| Pain: extremityMusculoskeletal and connective tissue disorders | 4/26 |
| NauseaGeneral disorders | 4/26 |
| Pain: esophagusGastrointestinal disorders | 4/26 |
| EsophagitisGastrointestinal disorders | 4/26 |
Patients who enrolled into the study and signed consent.
| Age, Categorical(Participants) | Single Arm Institution, Open Label, Phase II |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 27 |
| Age, Continuous(years) | Single Arm Institution, Open Label, Phase II |
|---|---|
| Mean | 49 ± 12.02326 |
| Sex: Female, Male(Participants) | Single Arm Institution, Open Label, Phase II |
|---|---|
| Female | 33 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm Institution, Open Label, Phase II |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Arm Institution, Open Label, Phase II |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Single Arm Institution, Open Label, Phase II |
|---|---|
| United States | 30 |
| Hungary | 1 |
| Puerto Rico | 1 |
| Norway | 1 |
| Patients enrolled were female gender over the age of 18.(participants) | Single Arm Institution, Open Label, Phase II |
|---|---|
| Number | 33 |
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M.D. Anderson Cancer Center