This trial is active, not recruiting.

Condition breast cancer
Treatments placebo, denosumab
Phase phase 3
Sponsor Amgen
Collaborator Austrian Breast and Colorectal Cancer Study Group
Start date December 2006
End date October 2014
Trial size 3425 participants
Trial identifier NCT00556374, 2005-005275-15, 20050209, ABCSG-18


The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Patients will be randomized 1:1 to receive denosumab 60 mg or placebo sub-cutaneously every 6 months.
(Placebo Comparator)
Patients will be randomized 1:1 to receive denosumab 60 mg or placebo sub-cutaneously every 6 months.

Primary Outcomes

The time to the first clinical fracture.
time frame:

Secondary Outcomes

The incidence of new vertebral fractures at Months 12, 24 and 36 months /End of Treatment visit.
time frame: Annually
The incidence of a new or worsening of pre-existing vertebral fractures at Months 12, 24 and 36 months/End of Treatment visit.
time frame: Annually
The percentage change in total lumbar spine, total hip and femoral neck bone mineral bone density from baseline to 12, 24 and 36 months/End of Treatment visit (at pre-selected sites).
time frame: Annually
Disease-free survival (DFS)
time frame: Annually
Bone metastasis-free survival (BMFS)
time frame: Annually
Overall survival (OS)
time frame: Annually

Eligibility Criteria

Female participants at least 45 years old.

Inclusion Criteria: - 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; - Subjects who are currently on, or will initiate an approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting; - Postmenopausal woman, 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. - More criteria may apply. Exclusion Criteria: - Aromatase inhibitor therapy for more than 24 months; - Prior or concurrent treatment with Selective Estrogen Receptor Modulators (eg, tamoxifen); - Evidence of metastatic disease; - Current or prior IV bisphosphonate administration; - Oral bisphosphonate treatment greater than or equal to 3 years continuously OR greater than 3 months but less than 3 years unless there was a washout period of at least 1 year prior to randomization OR any use during the 3-month period prior to randomization; - Prior administration of denosumab; - Known liver or renal deficiency; - Recurrence of the primary malignancy (eg, during the allowed interval of pretreatment with 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; - Any kind of disorder that compromises the ability to give written informed consent and/or comply with study procedures; - More criteria may apply.

Additional Information

Official title A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Amgen.