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Home > "D" Clinical Trials Conditions > Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer  Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer
Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer
For Condition: stage 3B breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): Lombardi Cancer Research 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 and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of doxorubicin with paclitaxel in treating women who have locally advanced breast cancer.
Details: OBJECTIVES: I. Assess the feasibility of obtaining serial biopsies in patients receiving neoadjuvant chemotherapy for locally advanced breast cancer. II. Assess the feasibility of performing assays of apoptosis and of markers that predict response on specimens obtained in these patients. III. Correlate the results of the assays with clinical and pathologic response rates. IV. Establish a baseline of change in apoptosis rates for future studies. V. Obtain serial blood samples and tumor tissue for future biological studies. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by pre or postmenopausal state and T3 or T4 lesions. Arm I: Patients receive single agent doxorubicin by bolus infusion on day 1. Dose repeats every 14 days for a total of four courses, provided absolute neutrophil count (ANC) and platelet count remain in the appropriate range. Patients then receive paclitaxel IV administered over 3 hours once every 14 days for a total of four courses, provided ANC and platelet count remain in the appropriate range. Filgrastim (G-CSF) subcutaneous treatment is started on day 3 of each course, and continued for 7 days, or until ANC is greater than 10,000/mm3. Patients undergo serial core-needle breast biopsies or fine needle aspirations prior to starting therapy and on day one of each course. Arm II: Patients receive four courses of paclitaxel given once every 14 days. Patients then receive four courses of doxorubicin given on day 1 every 14 days, provided ANC and platelet count are in the appropriate range. G-CSF subcutaneous treatment is started on day 3 of each course, as in Arm I. Patients undergo serial core-needle breast biopsies or fine needle aspirations prior to starting and on day one of each course. Arm I and II: Upon completion of eight courses of chemotherapy, patients undergo a surgical procedure to evaluate the extent of residual disease and number of lymph nodes involved, and to achieve local control. Following surgery, patients receive additional treatment at the discretion of the treating oncologist. Eligible patients undergo further high dose chemotherapy with peripheral blood stem cell rescue; other patients receive cyclophosphamide therapy. Patients receiving lumpectomies receive breast irradiation. Patients receiving mastectomies might receive chest wall irradiation. Following radiotherapy, hormone receptor positive patients may start tamoxifen therapy for 5 years. PROJECTED ACCRUAL: An estimated 40 patients (20 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven locally advanced breast cancer - Unresected T3 or T4 lesion, OR Unresected T2 lesion if patient considered appropriate candidate for neoadjuvant chemotherapy to enhance breast conservation - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior cytotoxic therapy - Endocrine therapy: No prior hormonal therapy for breast cancer; Prior estrogen replacement therapy allowed; No concurrent steroid therapy - Radiotherapy: Not specified - Surgery: See Disease Characteristics - Other: No concurrent treatment for serious infection (bacterial, viral, or fungal) --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-2 - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal - Renal: Creatinine no greater than 1.5 times normal - Cardiovascular: LVEF at least 50% (baseline MUGA); No history of uncontrolled congestive heart failure; At least 6 months since prior myocardial infarction; No unstable angina; No uncontrolled hypertension - Neurologic: No peripheral neuropathy - Other: Not pregnant or nursing; No psychosis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VeredStearns, Study Chair, Lombardi Cancer Research Center
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: CDR0000065642; GUMC-97018,NCI-V97-1276
Study Start Date: March 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003035
Other Stage 3a Breast Cancer Studies:
1. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
2. Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
3. Neoadjuvant Epirubicin, Cyclophosphamide, and Paclitaxel With or Without Gemcitabine in Treating Women With Early Breast Cancer
4. Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
5. HER-2 Protein Vaccine in Treating Women With Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer
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