Clinical trial · Interventional
Denosumab and MRI Breast Imaging
Phase II Correlative Study of Denosumab Effects on Tissue and Imaging Breast Biomarkers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently not receiving anticancer treatment with hormonal therapies, chemotherapy, or radiation. All patients will undergo quantification of breast density by MRI at baseline and after 6 months on denosumab. Because the therapeutic agent is an injectable drug, the investigators will conduct a single arm study with both pre- and post-treatment measurements to determine the extent of variability in breast density over time and a placebo treatment period or group will not be utilized. This is an investigator initiated trial and Amgen (SPONSOR) will provide the trial drug denosumab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Denosumab
- description
- 6 monthly subcutaneous injections of denosumab
- interventionNames
- Drug: Denosumab
Primary outcomes (1)
- measure
- Relative Change of ≥ 5% in Breast Density at 6 Months
- timeFrame
- baseline, 6 months
- description
- Breast density will be measured via non-contrast MRI before and after 6 months on denosumab
Secondary outcomes (1)
- measure
- Absolute Change > 1% in Breast Density
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pre or postmenopausal women with first incidence of early stage (stages 0 - III) breast cancer who have completed all treatment and are cancer-free, which includes women at high risk for developing invasive cancer i.e. having a breast biopsy positive for atypical ductal or lobular hyperplasia or carcinoma in situ. * Age ≤ 75 years * 44 patients will be accrued as follows: a) 22 evaluable patients will be premenopausal as defined as regular menses (24-38 days) b) 22 evaluable patients will be postmenopausal as defined by a history of amenorrhea for at least one year or hormone levels (estradiol/FSH) consistent with menopause if post-hysterectomy status, or history of surgical/medical castration. * Normal serum calcium or albumin-adjusted serum calcium between 2.0 and 2.9 mmol/L (8.0-11.5mg/dL). * Adequate vitamin D level (25-hydroxy vitamin D level \> 20 ng/mL) * Currently on no active treatment for breast cancer and at least 3 months post all the treatments, with the exception of aromatase inhibitors (exemestane, anastrozole, letrozole) * No prior or current use of IV bisphosphonates * No current use of oral bisphosphonates * Patients must have an unaffected, non-irradiated contralateral breast * Significant breast density as determined by mammography and defined by the descriptive terms scattered fibroglandular tissue/densities, heterogeneously dense, or mostly dense tissue in the mammography report. * Adequate renal function defined as a serum creatinine \< 1.5 x ULN or CrCl \> 30mL/min * A willingness and ability to follow the study protocol, as indicated by provision of informed consent to participate * Willingness to being tested for current pregnancy and use of birth control while being treated with denosumab (pre-menopausal women only) Exclusion Criteria: * Age \> 75 years * Subject has known sensitivity to any of the products to be administered during the study (e.g., mammalian derived products, denosumab, calcium, or vitamin D). * Patients have prior history or current evidence of osteonecrosis or osteomyelitis of the jaw. * Patients have active dental or jaw condition which requires oral surgery, including tooth extraction. * Patients have non-healed dental or oral surgery, including tooth extraction. * Patients with planned invasive dental procedures * Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of the treatment * Subject is of child bearing potential and is not willing to use, in combination with her partner, highly effective methods of contraception or abstinence during treatment and for 5 months after the end of treatment * Active infection with Hepatitis B, Hepatitis C, or Human Immunodeficiency virus (HIV) * Any condition or disorder that compromises the ability of the subject to provide written informed consent and/or comply with study procedures * History of claustrophobia * Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
References
Publications (0)
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