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Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00081510
Recruitment Status : Completed
First Posted : April 16, 2004
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Lonafarnib Drug: Placebo Drug: anastrozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2003
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

Arm Intervention/treatment
Experimental: Lonafarnib plus Anastrozole
Participants receive lonafarnib 200 mg orally (PO) twice per day (BID) beginning on Day 1 Cycle 1 and continuing until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole 1 mg, PO, once per day (QD) for as long as the participant is receiving lonafarnib
Drug: Lonafarnib
Other Name: SCH 66336

Drug: anastrozole
Active Comparator: Placebo plus Anastrozole
Participants receive placebo to lonafarnib PO BID beginning on Day 1 Cycle 1 until Progression of Disease, unacceptable toxicity, or other discontinuation criteria are met; and anastrozole, 1mg PO QD for as long as the participant is receiving placebo
Drug: Placebo
Drug: anastrozole

Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: When approximately 70 subjects have progressed ]

Secondary Outcome Measures :
  1. Objective response rate (adjusted RECIST criteria), duration of response, and overall survival [ Time Frame: When approximately 70 subjects have progressed ]
  2. To access the exposure and pk of lonafarnib and anastrazole in the subject population. [ Time Frame: When approximately 70 subjects have progressed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00081510    
Obsolete Identifiers: NCT00098904
Other Study ID Numbers: P03480
First Posted: April 16, 2004    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs