A Pilot Safety And Feasibility Study Of Concurrent Capecitabine (Xeloda) And External Beam Irradiation In The Adjuvant Treatment Of High Risk Early Stage Breast Cancer.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive adenocarcinoma of the breast,
meeting 1 of the following high-risk criteria:
- T3 or T4 primary tumor
- 4 or more involved axillary lymph nodes (N2 nodal stage)
- Completed surgical excision
- No immediate reconstruction with autologous flap reconstruction
- Patients having tissue expanders or implants placed prior to radiation may
be enrolled at the physician's discretion
- No residual breast cancer
- Microscopically positive margins are allowed if a re-excision is not felt to be
clinically justified
- Candidate for radiotherapy
- Must not require bilateral radiotherapy
- No metastatic (stage IV) breast cancer by AJCC staging criteria
- Hormone receptor status not specified
- No CNS disorders
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 6 months
- Karnofsky performance status 70-100%
- Menopausal status not specified
- Ambulatory
- Hemoglobin > 9 g/dL
- Platelet count > 100,000/mm³
- ANC > 1,500/mm³
- Serum AST, ALT, and alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
- Total bilirubin normal
- Creatinine clearance > 50 mL/min
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception during study and for 30 days after
the last study drug administration
- No serious, uncontrolled, concurrent infection(s)
- No diabetes with current or history of delayed wound healing or skin ulcers
- No autoimmune connective tissue disorder
- No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity
to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- No other carcinomas within the last five years except cured non-melanoma skin cancer
and in-situ cervical cancer
- No clinically significant cardiac disease (e.g., congestive heart failure,
symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with
medication) or myocardial infarction within the last 12 months
- No other serious uncontrolled medical conditions that the investigator feels might
compromise study participation, including any of the following:
- Uncontrolled seizures
- Psychiatric disability judged by the investigator to be clinically significant
- Physically intact upper gastrointestinal tract
- No malabsorption syndrome
- No uncompensated coagulopathy
- No patients whose breast size or body contour puts them at increased risk for skin
desquamation from standard radiotherapy
- Able to read and speak English
PRIOR CONCURRENT THERAPY:
- Fully recovered from surgery and chemotherapy with completely healed surgical wounds
- At least 4 weeks since completion of prior chemotherapy regimen, excluding
trastuzumab (Herceptin®)
- Concurrent trastuzumab allowed at the physician's discretion
- More than 4 weeks since prior participation in any investigational drug study
- At least 4 weeks since prior and no concurrent sorivudine or brivudine
- More than 2 weeks since prior major surgery
- No prior capecitabine
- No prior radiotherapy to the chest or ipsilateral lymphatics
- No concurrent hormonal therapy during course of chemotherapy or radiation therapy
- No concurrent allopurinol or cimetidine
- Concurrent coumadin is allowed