EUCTR2005-005275-15-AT进行中（未招募）1 期
A Randomized, Double- Blind, Placebo- Controlled, Multi- Center Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects with Non- Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy - ABCSG 18
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,400
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
- 性别
- Female
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the breast
- •Female subjects with non-metastatic disease who are estrogen receptor (ER) and/or progesterone receptor (PR) positive, and who have completed their treatment pathway (surgery, chemotherapy)
- •Subjects who are currently on, or will initiate an approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting
- •Postmenopausal woman (1,2), defined as a woman fulfilling any one of the following criteria:
- •Having undergone a bilateral oophorectomy;
- •Age > 60 years;
- •Aged < 60 years meeting the following requirements:
- •- FSH and estradiol in the postmenopausal range
- •- A negative pregnancy test within 7 days prior to randomization. Subjects who have undergone a hysterectomy do not require a pregnancy test.
- •(1) For subjects previously treated with an LHRH antagonist, the last dose must have been 4 months prior to randomization, and FSH and estradiol must be in the postmenopausal range.
- •(2) Subjects who have received adjuvant or neoadjuvant chemotherapy must have met 1 of the above criteria for postmenopausal status prior to that chemotherapy.
- •ECOG performance score of 0 or 1
- •Before any study-specific procedure is performed, a signed and dated written informed consent must be obtained
- •Inclusion Criteria for Post Open-label Denosumab Zoledronic Acid Extension (ZA Extension):
- •- Obtain signed and dated written informed consent prior to performing any study-specific procedure
- •- Subjects that received OLP denosumab and completed OLP treatment
- •- Last OLP denosumab administration no longer than 9 months ago
- •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 1492
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1908
排除标准
- •Aromatase inhibitor therapy for more than 24 months
- •Prior or concurrent treatment with Selective Estrogen Receptor Modulators ( SERMS), e. g. tamoxifen.
- •Evidence of metastatic disease
- •Current or prior IV bisphosphonate administration
- •Oral bisphosphonate treatment:
- •Greater than or equal to 3 years continuously
- •Greater than 3 months but less than 3 years unless subject has had a washout period of at least 1 year
- •Any use during the 3- month period prior to randomization
- •Known liver or renal deficiency as determined by the investigator and indicated by the following criteria:
- •AST > 2.5 x ULN
- •ALT > 2.5 x ULN
- •Serum creatinine > 2 x ULN
- •Prior administration of denosumab ( AMG 162)
- •Recurrence of the primary malignancy ( e. g. during the allowed interval of pretreatment with an aromatase inhibitor)
- •Diagnosis of any second non-breast malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri
- •Known history of any of the following conditions either by subject self report or chart review
- •Paget’s disease ( bone), Cushing’s disease, hyperprolactinemia, or other active metabolic bone disease
- •Hypercalcemia or hypocalcemia: as defined by calcium outside the normal range (A single value outside the normal range does not necessarily constitute hypercalcemia or hypocalcemia, but should be ‘corrected’ before including the subject. Subjects with a known history of hypercalcemia or hypocalcemia cannot be included)
- •Major surgery, or significant traumatic injury occurring within 4 weeks prior to randomization
- •Known Human Immunodeficiency Virus ( HIV) infection
- •Active infection with hepatitis B or hepatitis C virus
- •Any major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
- •Thirty days or less since receiving an investigational product or device in another clinical study
- •Known sensitivity to any of the products to be administered during the study ( e. g. mammalian derived products, calcium or vitamin D)
- •Subjects who are pregnant, breastfeeding, or plan to become pregnant during the course of the study. All subjects with reproductive potential must have a negative pregnancy test within 7 days before randomization
- •Any kind of disorder that compromises the ability to give written informed consent and/ or comply with study procedures
- •Exclusion Criteria for Post Open-label Denosumab Zoledronic Acid Extension
- •- Current or prior ZA administration.
- •- Subjects who ended treatment with investigational product (IP) prematurely in the double-blind phase and OL phase
- •- Known sensitivity or intolerance to any of the products to be administered during the study (eg, ZA, calcium or vitamin D)
- •- Known history of any of the following conditions either by subject self report or chart review
- •Paget’s disease (bone), Cushing’s disease, hyperprolactinemia or other active metabolic bone disease
- •Known history of hypocalcemia
- •Major surgery, or significant traumatic injury occurring within 4 weeks prior to randomization
- •Parathyroid glands in neck surgically removed
- •Any sections of intestine removed
- •Known human immunodeficiency virus infection
- •Active infection with hepatitis B or hepatitis C virus
- •- Known liver or renal disease as determined by the investigator and indica
研究者
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