EUCTR2008-002119-42-ES进行中（未招募）1 期
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 Spanish title: Estudio de Fase III para evaluar la tolerabilidad y eficacia de MK-0822 (Odanacatib) en la reducción del riesgo de desarrollar metástasis óseas y en la prolongación de la supervivencia libre de progresión en mujeres con cáncer de mama” - MK-0822 (Odanacatib) in Women with Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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)
- •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
排除标准
- •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.
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