A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: odanacatib
Comparator: placebo
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Confirmed primary State II or Stage III breast cancer
- Patient is not receiving adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) at the time of randomization and has not received adjuvant chemotherapy for at least 6 weeks prior to the randomization visit (Visit 2). This inclusion criterion does not include hormone therapy, which is permitted (see inclusion criterion # 7)
- 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)
Exclusion Criteria:
- 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 has a history of malignancy other than breast cancer <5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are exclusionary
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
odanacatib
placebo
Outcomes
Primary Outcome Measures
to assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo
Secondary Outcome Measures
to assess the effect of treatment with MK0822 5 mg once daily on disease-free survival compared to placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00692458
Brief Title
A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)
Official Title
A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK0822 (Odanacatib) in Reducing the Risk of Bone Metastasis in Women With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn for administrative reasons
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
September 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women with breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
odanacatib
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Comparator: odanacatib
Intervention Description
odanacatib; 5mg oral, once daily for approximately 60 months.
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
placebo; oral, once daily for approximately 60 months
Primary Outcome Measure Information:
Title
to assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo
Time Frame
approximately 60 months (event driven study)
Secondary Outcome Measure Information:
Title
to assess the effect of treatment with MK0822 5 mg once daily on disease-free survival compared to placebo
Time Frame
approximately 60 months (event driven study)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed primary State II or Stage III breast cancer
Patient is not receiving adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) at the time of randomization and has not received adjuvant chemotherapy for at least 6 weeks prior to the randomization visit (Visit 2). This inclusion criterion does not include hormone therapy, which is permitted (see inclusion criterion # 7)
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)
Exclusion Criteria:
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 has a history of malignancy other than breast cancer <5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are exclusionary
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)
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