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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

Phase 3
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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

- 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:

1. is currently receiving a bisphosphonate or other drug therapy for osteoporosis

2. 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

3. 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

approximately 60 months (event driven study)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Neoplasm Metastasis