Phase 2
Completed N=33
Xeloda (Capecitabine) and External Beam Radiation
Source: ClinicalTrials.gov NCT00916578 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: 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
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
26 | — |
Eligibility Criteria
Inclusion Criteria
- Histological confirmation of invasive breast cancer
- 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)
- 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).
- Are able to swallow and retain oral medication (intact pill)
- Age over 18
- Female gender
Exclusion Criteria
- Have an active or uncontrolled infection
- Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Have used an investigational drug within 21 days preceding the first dose of study medication
- Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)
- Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam
- Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.
Data sourced from ClinicalTrials.gov (NCT00916578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.