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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. Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
2. A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy with G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients
3. Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
4. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
5. Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer
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Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer
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