Denosumab and MRI Breast Imaging

NCT02613416 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 706513
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Relative Change of ≥ 5% in Breast Density at 6 Months

  Breast density will be measured via non-contrast MRI before and after 6 months on denosumab

  baseline, 6 months

Secondary Outcomes (1)

• Absolute Change > 1% in Breast Density

  6 months

Study Arms (1)

Denosumab

EXPERIMENTAL

6 monthly subcutaneous injections of denosumab

Drug: Denosumab

Interventions

Denosumab DRUG

monthly subcutaneous injections

Also known as: XGEVA

Denosumab

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alison Stopeck: lead
• Amgen: collaborator

Study Sites (1)

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Caterina Vacchi-Suzzi
• Organization: Stony Brook University

caterina.vacchi-suzzi@stonybrookmedicine.edu

631-444-8074

Study Officials

• Alison Stopeck, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)