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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00081510

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Lonafarnib plus Anastrozole Drug: Placebo plus Anastrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Lonafarnib

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Progression-free survival (PFS) [ Time Frame: When approximately 70 subjects have progressed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	124
Study Start Date:	December 2003
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lonafarnib plus Anastrozole: Experimental	Drug: Lonafarnib plus Anastrozole Lonafarnib 200 mg PO BID beginning on Cycle 1 Day 1 and continuously until Progression of Disease, unacceptable toxicity, or other discontinuation criteria. Subjects will be treated concomitantly with anastrozole (1 mg PO QD) continuously.
Placebo plus Anastrozole: Active Comparator	Drug: Placebo plus Anastrozole Placebo PO BID beginning on Cycle 1 Day 1 and continuously until Progression of Disease, unacceptable toxicity, or other discontinuation criteria. Subjects will be treated concomitantly with anastrozole (1 mg PO QD) continuously.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081510

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03480
Study First Received:	April 14, 2004
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00081510
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009