A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)

NCT00692458 | Withdrawn Phase 3

• 3 other identifiers: 0822-0292008_526MK-0822-029
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women with breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• to assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo

  approximately 60 months (event driven study)

Secondary Outcomes (1)

• to assess the effect of treatment with MK0822 5 mg once daily on disease-free survival compared to placebo

  approximately 60 months (event driven study)

Study Arms (2)

1

EXPERIMENTAL

odanacatib

Drug: Comparator: odanacatib

2

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

Comparator: odanacatib DRUG

odanacatib; 5mg oral, once daily for approximately 60 months.

1

Comparator: placebo DRUG

placebo; oral, once daily for approximately 60 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed primary State II or Stage III breast cancer
• Patient is not receiving hormonal therapy OR if patient is receiving hormonal therapy (e.g., leuprolide, tamoxifen, anastrozole) she is on a stable regimen for at least 3 months at the time of screening (Visit 1). If patient is HER2-positive and is receiving trastuzumab treatment, she must be on a stable regimen for at least 1 month at the time of Visit 1
• Patient is not pregnant or breast-feeding. All women of childbearing potential must have a negative urine pregnancy test at screening (Visit 1)

You may not qualify if:

• Bone metastases or history of bone metastases
• Patient has evidence of other distant metastases (e.g., visceral, soft-tissue, or brain)
• Patient has had a prior local or regional recurrence of her breast cancer, or a contralateral tumor. DCIS (ductal carcinoma in-situ), and LCIS (local carcinoma in-situ) in either the ipsilateral or contralateral breast are permitted
• Patient has ANY of the following:
• is currently receiving a bisphosphonate or other drug therapy for osteoporosis
• has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to Visit 1, or for a total of more than 6 months at any time prior to Visit 1
• has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1
• Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
• Patient is currently participating in or has at any time in the past participated in a breast cancer study with a registered medication (i.e., approved by the regulatory agency in which she resides) being tested for the treatment of breast cancer (an unapproved indication)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 12, 2016

Record last verified: 2015-11