Breast Cancer
Conditions
Keywords
Advanced Inflammatory Breast Cancer, Non-Inflammatory Breast Cancer, Capecitabine, Xeloda, Concomitant Radiation, Radiation Therapy, Radiotherapy, Women
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONRadiation Therapy
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.
DRUGCapecitabine
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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological confirmation of invasive breast cancer 2. No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication) 3. Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast). 4. Are able to swallow and retain oral medication (intact pill) 5. Age over 18 6. Female gender
Exclusion criteria
1. Have an active or uncontrolled infection 2. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent 3. Have used an investigational drug within 21 days preceding the first dose of study medication 4. Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin) 5. Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam 6. Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Participants were monitored from 2009 to 2012. | The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Institution, Open Label, Phase II The protocol was a Single Arm study in which eligible patients were women with a diagnosis of invasive breast cancer with primary or recurrent gross disease in the breast or chest wall or lymph nodes that is progressive, persistent, or minimally responsive to chemotherapy. Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Tradition therapy does will be 50-57 Gy to the initial clinical target volume. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insurance Denial | 2 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Single Arm Institution, Open Label, Phase II |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 12.02326 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Patients enrolled were female gender over the age of 18. | 33 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment Hungary | 1 participants |
| Region of Enrollment Norway | 1 participants |
| Region of Enrollment Puerto Rico | 1 participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 18 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
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.
Population: All patients who received protocol - specified treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 participants |