|
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer Clinical research trials and Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer. Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer clinical trial. Participants frequently get the best healthcare available for their Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer  Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Schering-Plough ,
Synopsis: Primary Objective(s): - To compare the activity (progression-free survival, PFS) of anastrozole in combination with lonafarnib to that of anaastrozole in combination with placebo in subjects with hormone-sensitive advanced breast cancer. Secondary Objective(s): - To determine the effects of anastrozole in combination with lonafarnib on objective of lonafarnib and anastrozole to the subject population.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Diagnosis & criteria for inclusion: - Postmenopausal women with a histologicaly confirmed diagnosis of hormone receptor (estrogen receptor and/or progresterone receptor) positive locally advanced or metastatic breast cancer (Stage 3b, 3c, or 4). - No prior hormonal therapy or chemotherapy for advanced disease. Prior radiotherapy is permitted. - Subjects relapsing in adjuvant tamoxifen therapy or after discontinuing adjuvant tamoxifen are eligible as long as the disease-free interval from discontinuation of tamoxifen treatment to diagnosis of advanced/metastatic disease is at least 12 months. - Subjects taking bisphosphonates who are stable are allowed on the study. Measurable disease (masses with clearly defined margins on radiological images and at least one diameter less than 20mm) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter less than 20mm). Subjects with bone disease only are permitted if disease is evaluable. Inclusion Criteria: - ECOG Performance Status of 0 or 1. - Subjects with brain metastases are excluded. - Sufficient bone marrow reserved - Adequate hepatic function: laboratory values within protocol requirements. - Friderica QTc (QTcF) interval less than 470 msec: no symptomatic arrhythmias, greater than first degree AV block, or a documented ischemic event. - No prior treatment with FTIs. - Subjects with a known or suspected hypersensitivity to any excipietns in the lonafarnib formulation (Povidone, Poloxamer 188, croscarmellose soldium, silicon dioxice, and magnesium stearate) are excluded.
Total Enrollment: 110
Location and Contact Information:
Instituto Oncologico Nacional *Recruiting*
Panama, ,
Panama
Recruiting Enrique Correa 507-212-7179
Additional Information:
Study ID Numbers: P03480;
Study Start Date: December 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081510
Other Breast Cancer Studies:
1. Study of two doses of ALIMTA (pemetrexed) as first line chemotherapy for advanced breast cancer
2. Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Preventing Cancer in Women at High Risk For Developing Breast Cancer
3. A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.
4. Treatment with Zometa in patients with breast cancer, multiple myeloma, and prostate cancer with cancer related bone lesions
5. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Related Studies:
Other Breast Cancer Clinical Trials
Other Clinical Trials
Other Panama Clinical Trials
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer
|
|
|
|
|
|
|
|
