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Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer Clinical research trials and Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer. Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer  Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Arbeitsgemeinschaft fur Internistische Onkologie ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if mitoxantrone is more effective with or without docetaxel. PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
Details: OBJECTIVES: - Compare the survival and quality of life scores (composed of time to progression, WHO performance status, subjective patient evaluation, and subjective adverse event profile) among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease. - Compare the remission rate, time to remission, remission duration, time to best response, objective adverse events, and patient acceptance of treatment on these 2 regimens. - Investigate which prognostic subgroups of women benefit from treatment. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, treatment center, disease free interval (no more than 18 months vs more than 18 months), hormone receptor status (positive or unknown vs negative), prior adjuvant therapy with anthracyclines (yes vs no), presence of liver metastases (liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement), and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive mitoxantrone IV on day 1. Treatment repeats every 3 weeks until disease progression, unacceptable toxicity, or maximum cumulative dose. Patients who achieve complete response receive 2 additional courses. - Arm II: Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. At relapse, reinduction with the original regimen is attempted. Following a second complete response, 2 additional courses of consolidative treatment are given, and patients are then followed off treatment. Quality of life is assessed periodically. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven metastatic breast cancer of poor prognosis, defined by any of the following characteristics: - Patient aged 35 or under - Liver metastases - Lung metastases combined with other disease manifestations - Lung metastases without other disease manifestations but with a disease free interval of no more than 18 months - Indication for chemotherapy documented by either: - Hormone receptor negativity OR - Hormone resistant disease - Measurable metastatic disease required - Nonmeasurable disease includes: - Metastases verified only histologically - Tumor parameters not precisely measurable (e.g., bone marrow involvement, lymphangitic disease) - No CNS metastasis or bone marrow carcinomatosis - Hormone receptor status: - Receptor status known PATIENT CHARACTERISTICS: Age: - 80 and under Sex: - Female Menopausal status: - Not specified Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC greater than 4,000/mm^3 - Absolute granulocyte count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 6 times ULN - SGOT and/or SGPT no greater than 3 times ULN Renal: - Creatinine no greater than 1.15 times ULN Cardiovascular: - No uncontrolled hypertension - No congestive heart failure within the past 6 months - No myocardial infarction within the past 6 months Other: - Fertile patients must use effective contraception - No acute or chronic infection - No second primary tumor - No other serious illness PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biologic therapy Chemotherapy: - No prior chemotherapy for metastatic disease - Greater than 1 year since prior adjuvant chemotherapy - No prior anthracycline or anthraquinone Endocrine therapy: - Hormone resistant disease required of receptor positive patients - No concurrent endocrine therapy Radiotherapy: - No prior mediastinal irradiation - Adjuvant irradiation of parasternal nodes eligible - No prior irradiation to more than 25% of bone marrow - No concurrent irradiation of sole measurable lesion Surgery: - Not specified Other: - No concurrent anticoagulant therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElseHeidemann, Study Chair, Diakonissen-Krankenhaus Stuttgart
Diakonissen-Krankenhaus Stuttgart
Stuttgart, , D-70176
Germany
Additional Information:
Study ID Numbers: CDR0000063279; GER-AIO-01/92,EU-93011
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002544
Other Recurrent Breast Cancer Studies:
1. Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
2. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
3. Docetaxel in Treating Older Women With Metastatic Breast Cancer
4. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
5. Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
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Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
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