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Home > "A" Clinical Trials Conditions > Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer  Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer
Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer
For Condition: Male Breast Cancer,stage 2 breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): Yale Cancer Center ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven adenocarcinoma of the breast with involvement of 4 or more axillary nodes, including any T, N, 1, 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraBurtness, Study Chair, Yale Cancer Center
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000064337; YALE-HIC-7374,NCI-V95-0720
Study Start Date: February 1994
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002679
Other Stage 2 Breast Cancer Studies:
1. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer
2. Comparison of Biological Therapies Following Combination Chemotherapy and Bone Marrow or Peripheral Stem Cell Transplantation in Women With Stage II or Stage III Breast Cancer
3. Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
4. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
5. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer
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