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.
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.