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About
This is a prospective, single arm phase IIa trial in which patients with early breast cancer will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be collected at baseline and at surgery. Post-operative treatment will be at the discretion of the investigator.
Primary objective: to determine if a short course of RANKL inhibition with denosumab can induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women.
Secondary objectives:
Enrollment
Sex
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Volunteers
Inclusion criteria
Female gender
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Premenopausal status defined as the presence of active menstrual cycle or normal menses during the 6 weeks preceding the start of study treatment. Biochemical evidence of phase of menstrual cycle is required (estradiol, FSH and LH). In women previously exposed to hysterectomy,or were using hormonal intrauterine device at the time of enrolment, premenopausal levels of estradiol, FSH and LH are required to be eligible
Non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:
Known HER2 status
Known estrogen receptor (ER) status and progesterone receptor status (PgR)
Patient has adequate bone marrow and organ function as shown by:
Albumin-adjusted serum calcium ≥ 8.0 mg/dL (≥ 2.0 mmol/L)
Women of childbearing potential must agree to use an active local contraception method for the duration of the study and for at least 7 months after the last dose of study treatment
Patients must accept to take calcium and vitamin D supplementation until the completion of the study treatment
Signed informed consent form (ICF) for all study procedures according to local regulatory requirements prior to beginning of the study
Patients must accept to make available tumor and normal tissue samples for submission to central laboratory at the Jules Bordet Institute, Brussels, Belgium, to conduct translational studies as part of this protocol.
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27 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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