A Phase III Study to Assess the Tolerability and Efficacy of MK-0822 (Odanacatib) in Reducing the Risk of Bone Metastases and Prolonging Disease-Free Survival in Women with Breast Cancer - MK-0822 (Odanacatib) in Women with Breast Cancer

Phase 1

• Conditions: Prevention of disease recurrence in patients with breast cancer.; MedDRA version: 9.1Level: LLTClassification code 10005993Term: Bone metastases

• Registration Number: EUCTR2008-002119-42-SK
• Lead Sponsor: Merck& Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-01
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

• Patient is a woman =18 years of age on the day of signing the informed consent
• Patient has histologically and/or cytologically confirmed primary Stage II or Stage III breast cancer (must be lymph-node positive and/or with a tumor size >2 cm). regardless of HER-2 status. Stage I patients who are HER-2 positive based either on immunohistochemistry or fluorescent in situ hybridization (FISH technique), or who have a positive genetic signature for breast cancer recurrence using the Celera 14-gene MetaScore, or Genomic Health Oncotype DX, or Mammaprint, are also eligible.
• If ER-negative breast cancer, patient has been diagnosed up to 2 years prior to study entry (Visit 1)

OR

• If ER-positive breast cancer, patient has been diagnosed up to 5 years prior to study entry (Visit 1)
• Patient has undergone antineoplastic surgery and has recovered, and is at least 2 weeks from previous antineoplastic surgery at the time of screening (Visit 1).
• Patient has not received adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) or has completed adjuvant chemotherapy 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. Patients must also remain on this stable regimen between Visit 1 and Visit 2.
• Patient has not undergone radiotherapy, OR if patient has undergone radiotherapy, she has recovered and is at least 4 weeks from the previous radiotherapy at the time of screening (Visit 1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patient has bone metastases, or has a history of bone metastases: patient must have a negative bone scan obtained during the screening period, or within 1 month prior to the screening visit (Visit 1). All bone scans and associated imaging studies used for eligibility purposes must be adjudicated by the central radiologist before the patient can be randomized at Visit 2.
• 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 (lobular carcinoma in-situ) in either the ipsilateral or contralateral breast are permitted.
• Patient has ANY of the following:
a) is currently receiving a bisphosphonate (e.g., etidronate, clodronate, tiludronate, pamidronate, alendronate, ibandronate, risedronate, olpadronate, neridronate, zoledronate), or other drug therapy for osteoporosis.
b) has been treated with an oral bisphosphonate within the 6 months prior to Visit 1.
c) has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1.
• Patient is using any of the following potent inhibitors of CYP3A4 within 2 weeks prior to starting blinded study medication: (a) systemically or vaginally administered azole antifungals such as ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole; (b) nefazodone; (c) the macrolide antibiotics clarithromycin, dirithromycin, erythromycin, and troleandomycin, however, azithromycin, is permitted. The use of any other macrolide antibiotic requires approval by the SPONSOR’s clinical representative. Patients who discontinue these medications at least two weeks prior to starting blinded study medication are eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified