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Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer Clinical research trials and Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer  Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
For Condition: stage 3C breast cancer,inflammatory breast cancer,stage 2 breast cancer,stage 3A breast cancer,stage 3B breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells. PURPOSE: Phase II trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.
Details: OBJECTIVES: - Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel, in terms of the absence of any grade 3 or higher toxicity (aside from alopecia), in women with high-risk stage I-III breast cancer. OUTLINE: This is a pilot study. - Neoadjuvant or adjuvant EC therapy: Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV (EC) on day 1 and filgrastim (G-CSF) subcutaneously on days 2-9 or 10. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Neoadjuvant or adjuvant paclitaxel therapy: After the completion of EC therapy, patients receive paclitaxel IV over 3 hours on day 1. Patients also receive G-CSF as in EC therapy. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy. Patients also may receive adjuvant radiotherapy and/or hormonal therapy at the discretion of the treating physician. Patients are followed every 4 months for 3 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 11-38 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Stage I, II, or III - Inflammatory breast cancer allowed - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR - SGOT/SGPT no greater than ULN AND alkaline phosphatase no greater than 4 times ULN Renal - Not specified Cardiovascular - LVEF at least lower limit of normal by MUGA or echocardiogram - No unstable angina - No congestive heart failure - No arrhythmia requiring medical therapy - No myocardial infarction within the past year Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergy/hypersensitivity to any of the study drugs or other drugs formulated with Cremophor EL - No psychiatric illness that would preclude understanding of the nature of the study or study compliance - No active unresolved infection - No peripheral neuropathy greater than grade 1 - No other nonmammary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No concurrent medical condition that would preclude study participation in the judgment of the investigator PRIOR CONCURRENT THERAPY: Biologic therapy - More than 12 months since prior immunotherapy for prior breast cancer - No prior or concurrent biologic therapy or immunotherapy for this breast cancer Chemotherapy - More than 12 months since prior chemotherapy for prior breast cancer - No prior anthracycline (i.e., doxorubicin or epirubicin) and taxane therapy - No prior or other concurrent chemotherapy for this breast cancer Endocrine therapy - No concurrent hormonal therapy for chemoprevention - Prior hormonal therapy for chemoprevention allowed - No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormonal replacement therapy) Radiotherapy - No prior radiotherapy - No other concurrent radiotherapy for this breast cancer Surgery - Not specified Other - No concurrent digitalis, beta-blockers, or calcium channel blockers for congestive heart failure
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MonicaFornier, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Clifford Hudis 212-639-6483
Additional Information:
Study ID Numbers: CDR0000339599; MSKCC-03092
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072319
Other Stage 3a Breast Cancer Studies:
1. Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer
2. Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
3. Combination Chemotherapy in Treating Patients With Stage III Breast Cancer
4. Chemotherapy in Treating Patients With Breast Cancer
5. Timing of Menstrual Cycle and Surgery in Treating Premenopausal Women With Stage I, Stage II, or Stage III Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
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