Breast Cancer
Conditions
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, male breast cancer, recurrent breast cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.
Detailed description
OBJECTIVES: Primary * To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer. Secondary * To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year. * To determine the short-term (1-year) risk of recurrence of breast cancer in these patients. OUTLINE: This is a multicenter study. Patients undergo external-beam radiotherapy once daily, 5 days a week and concurrently receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately 6-7 weeks. After completion of study therapy, patients are followed at approximately 1 week, 1 month, 6 months, and 12 months.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Safety | 1 year | Primarily Grade 1 and 2 toxicities attributable to capecitabine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis | 1 year | — |
| Recurrence | 1 year | This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgery and Chemotherapy 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 | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | not stated | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Surgery and Chemotherapy |
|---|---|
| adjuvant | 28 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 52 years |
| masectomy | 6 Participants |
| neo-adjuvant | 14 Participants |
| partial masectomy | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 39 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 39 |
| other Total, other adverse events | 8 / 39 |
| serious Total, serious adverse events | 6 / 39 |
Outcome results
Overall Safety
Primarily Grade 1 and 2 toxicities attributable to capecitabine
Time frame: 1 year
Population: Radiation given based on planned- 50.4cGy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgery and Chemotherapy | Overall Safety | 12.6 percentage of participants |
Cosmesis
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgery and Chemotherapy | Cosmesis | 22 participants |
Recurrence
This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgery and Chemotherapy | Recurrence | 14 percentage of participants |