Intervention: Capecitabine
Trial phase: Phase 2
ATC code: L01BC06
SMILES: CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.

capecitabine

adjuvant therapy

radiation therapy
Eligibility 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