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Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy Clinical research trials and Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy. Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy clinical trial. Participants typically obtain the most effective healthcare available for their Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy  Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.
Details: OBJECTIVES: - Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy. - Determine the best overall response rate of patients treated with this drug. - Determine the progression-free survival of patients treated with this drug. - Determine the duration of response in patients treated with this drug. - Determine the safety of this drug in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Radiological and/or clinical evidence of metastatic disease - Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last treatment before study entry - Unidimensionally measurable disease - No rapidly progressive visceral metastases - No uncontrolled CNS metastases - Hormone receptor status: - Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age - 18 and over Sex - Not specified Menopausal status - Postmenopausal, defined as any of the following: - Natural menopause with at least 1 year since last menses - Radiation-induced oophorectomy with last menses more than 1 year ago - Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels in the postmenopausal range - Surgical castration Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Transaminases no greater than 2.5 times ULN - No severe or uncontrolled hepatic disease Renal - No severe or uncontrolled renal disease Cardiovascular - No severe or uncontrolled cardiac disease Pulmonary - No severe or uncontrolled respiratory disease - No evidence of clinically active interstitial lung disease - Asymptomatic chronic stable radiographic changes allowed Other - No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up - No other severe or uncontrolled systemic disease - No known hypersensitivity to any excipients of gefitinib - No unresolved chronic toxicity greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic agents Chemotherapy - No more than 1 prior chemotherapy regimen for metastatic breast cancer - No concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent hormonal therapy Radiotherapy - Prior radiotherapy allowed - No concurrent radiotherapy to any metastatic site Surgery - No surgery within 4 days after study drug administration Other - No prior epidermal growth factor receptor inhibitor therapy - More than 30 days since prior investigational drugs - No concurrent use of any of the following: - Phenytoin - Carbamazepine - Rifampin - Phenobarbital - Hypericum perforatum (St. John's Wort) - No concurrent systemic retinoids - No other concurrent investigational drugs or treatments - No other concurrent anticancer treatments - Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment* NOTE: *Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinePiccart-Gebhart, , Institut Jules Bordet
Institut Jules Bordet
Brussels, , 1000
Belgium
Additional Information:
Study ID Numbers: CDR0000315533; EORTC-10012,IDBBC-10012
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066339
Other Recurrent Breast Cancer Studies:
1. Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
2. Chemotherapy in Treating Patients With Breast Cancer
3. Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
4. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
5. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
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Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
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