Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (Study P03480AM5)(COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	April 14, 2004
Last Updated Date	October 1, 2009
Start Date ^ICMJE	December 2003
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 1, 2008)	Progression-free survival (PFS) [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Progression-free survival (PFS), as determined by the central radiology evaluation [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00081510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Objective response rate (adjusted RECIST criteria), duration of response, and overall survival [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: Yes ] To access the exposure and pk of lonafarnib and anastrazole in the subject population. [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (Study P03480AM5)(COMPLETED)
Official Title ^ICMJE	A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer
Brief Summary	Primary Objective(s): To compare the activity (progression-free survival [PFS]) of anastrozole in combination with lonafarnib to that of anastrozole 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 response, duration of response, overall survival, and safety in subjects with advanced breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Drug: Lonafarnib plus Anastrozole Drug: Placebo plus Anastrozole
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	124
Completion Date	October 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Postmenopausal women who have histologically-confirmed breast cancer with the following characteristics: estrogen and/or progesterone receptor positive, locally advanced disease distant metastatic disease, stage 4 Subjects eligible for single-agent treatment with aromatase inhibitors for current disease. Subjects taking biophosphonates are allowed if they begin bisphosphonate therapy AT LEAST two weeks prior to randomization. Measurable disease (masses with clearly defined margins on radiological images and at least one diameter >=20 mm[>=10 mm if spiral CT]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter >= 20 mm). Subjects with bone disease only are permitted if disease is evaluable. ECOG Performance Status of 0 or 1. Sufficient bone marrow reserve. Adequate hepatic and renal function: laboratory values within protocol requirements. Exclusion Criteria: Subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease. Subjects with with CLINICALLY APPARENT brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor. Subjects with prior treatments with FTIs. Subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (Providone, Poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).
Gender	Female
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00081510
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	P03480
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP