Denosumab and MRI Breast Imaging

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Collaborator: Amgen
• Treatments: Denosumab

Criteria

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.