adjuvant high-dose, sequential chemotherapy in treating patients with resected breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of high-dose sequential chemotherapy as adjuvant therapy in treating patients with stage ii or stage iii breast cancer who have four or more positive axillary lymph nodes.

objectives: i. evaluate the efficacy of dose intensive, sequential adjuvant chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide in patients with stage ii/iii resected breast cancer. ii. evaluate the toxicity of this regimen in these patients. outline: all patients receive sequential chemotherapy regimens consisting of 3 courses each of doxorubicin, paclitaxel, and cyclophosphamide on a schedule of one course every 14 days. following completion of chemotherapy, patients who underwent breast conservation surgery receive radiotherapy. mastectomy patients with 10 or more positive nodes or with t3-4 tumors are also eligible for delayed radiotherapy. patients who are hormone receptor positive (or whose receptor status is unknown) are treated with oral tamoxifen for 5 years, beginning after completion of all other therapy. patients are followed every 3 months for 2 years, every 6 months for 3 years, then yearly. projected accrual: at total of 90 patients will be entered.

Eligibility criteria:
disease characteristics: histologically proven adenocarcinoma of the breast with involvement of 4 or more axillary nodes, including any t n1 m0 concurrent bilateral breast cancer allowed complete resection required total mastectomy or breast conserving surgery adjuvant radiotherapy planned after protocol chemotherapy clear surgical margins axillary dissection yielding at least 9 lymph nodes entry required within 8 weeks of definitive surgery hormone receptor status: any status patient characteristics: age: over 18 sex: not specified menopausal status: not specified performance status: karnofsky 80%-100% ecog 0 or 1 hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 10 g/dl hepatic: bilirubin no greater than 1.5 times normal ast no greater than 2 times normal alkaline phosphatase no greater than 2 times normal renal: creatinine no greater than 1.8 mg/dl or creatinine clearance at least 60 ml/min urinalysis normal cardiovascular: left ventricular ejection fraction normal on muga or echocardiogram no congestive heart failure requiring medical therapy no serious arrhythmia no first-, second-, or third-degree heart block other: no abnormal ct of chest or abdomen no uncontrolled infection no serious medical condition that would prevent treatment no second malignancy except curatively treated: nonmelanomatous skin cancer carcinoma in situ of the cervix not pregnant negative pregnancy test barrier contraception required of fertile patients before, during, and for 6 months after protocol therapy prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior systemic chemotherapy endocrine therapy: no concurrent hormonal therapy unless unrelated to cancer radiotherapy: see disease characteristics surgery: see disease characteristics other: no concurrent medication affecting conduction unless cleared by a cardiologist, e.g.: beta blockers digoxin antiarrhythmia agents calcium channel blockers

Keywords: stage ii breast cancer stage iiia breast cancer male breast cancer