Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments radiation therapy, capecitabine
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Start date June 2009
End date July 2017
Trial size 60 participants
Trial identifier NCT00916578, 2009-0087, NCI-2012-01266

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 therapy RT
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.
capecitabine Xeloda
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.

Primary Outcomes

Measure
Tumor Response (complete response + partial response) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
time frame: Assessed 4 weeks (+/- 4 days) after the last scheduled day of radiation

Eligibility Criteria

Female participants at least 18 years old.

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 CHF based on clinical history or physical exam 6. Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.

Additional Information

Official title A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.