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A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer

The Study Treatment:

Radiation therapy and capecitabine are both designed to interfere with the growth of cancer

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

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response (complete response + partial response) as measured by RECIST criteria

Outcome Time Frame:

Assessed 4 weeks (+/- 4 days) after the last scheduled day of radiation

Safety Issue:


Principal Investigator

Wendy Woodward, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Advanced Inflammatory Breast Cancer
  • Non-Inflammatory Breast Cancer
  • Capecitabine
  • Xeloda
  • Concomitant Radiation
  • Radiation Therapy
  • Radiotherapy
  • Women
  • Breast Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030