Denosumab and MRI Breast Imaging
- Conditions
- Breast Cancer
- Registration Number
- NCT02613416
- Lead Sponsor
- Alison Stopeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 42
Inclusion Criteria:<br><br> - Pre or postmenopausal women with first incidence of early stage (stages 0 - III)<br> breast cancer who have completed all treatment and are cancer-free, which includes<br> women at high risk for developing invasive cancer i.e. having a breast biopsy<br> positive for atypical ductal or lobular hyperplasia or carcinoma in situ.<br><br> - Age = 75 years<br><br> - 44 patients will be accrued as follows: a) 22 evaluable patients will be<br> premenopausal as defined as regular menses (24-38 days) b) 22 evaluable patients<br> will be postmenopausal as defined by a history of amenorrhea for at least one year<br> or hormone levels (estradiol/FSH) consistent with menopause if post-hysterectomy<br> status, or history of surgical/medical castration.<br><br> - Normal serum calcium or albumin-adjusted serum calcium between 2.0 and 2.9 mmol/L<br> (8.0-11.5mg/dL).<br><br> - Adequate vitamin D level (25-hydroxy vitamin D level > 20 ng/mL)<br><br> - Currently on no active treatment for breast cancer and at least 3 months post all<br> the treatments, with the exception of aromatase inhibitors (exemestane, anastrozole,<br> letrozole)<br><br> - No prior or current use of IV bisphosphonates<br><br> - No current use of oral bisphosphonates<br><br> - Patients must have an unaffected, non-irradiated contralateral breast<br><br> - Significant breast density as determined by mammography and defined by the<br> descriptive terms scattered fibroglandular tissue/densities, heterogeneously dense,<br> or mostly dense tissue in the mammography report.<br><br> - Adequate renal function defined as a serum creatinine < 1.5 x ULN or CrCl > 30mL/min<br><br> - A willingness and ability to follow the study protocol, as indicated by provision of<br> informed consent to participate<br><br> - Willingness to being tested for current pregnancy and use of birth control while<br> being treated with denosumab (pre-menopausal women only)<br><br>Exclusion Criteria:<br><br> - Age > 75 years<br><br> - Subject has known sensitivity to any of the products to be administered during the<br> study (e.g., mammalian derived products, denosumab, calcium, or vitamin D).<br><br> - Patients have prior history or current evidence of osteonecrosis or osteomyelitis of<br> the jaw.<br><br> - Patients have active dental or jaw condition which requires oral surgery, including<br> tooth extraction.<br><br> - Patients have non-healed dental or oral surgery, including tooth extraction.<br><br> - Patients with planned invasive dental procedures<br><br> - Subject is pregnant or breast feeding, or planning to become pregnant within 5<br> months after the end of the treatment<br><br> - Subject is of child bearing potential and is not willing to use, in combination with<br> her partner, highly effective methods of contraception or abstinence during<br> treatment and for 5 months after the end of treatment<br><br> - Active infection with Hepatitis B, Hepatitis C, or Human Immunodeficiency virus<br> (HIV)<br><br> - Any condition or disorder that compromises the ability of the subject to provide<br> written informed consent and/or comply with study procedures<br><br> - History of claustrophobia<br><br> - Have electrically, magnetically, or mechanically activated implants including<br> cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative Change of = 5% in Breast Density at 6 Months
- Secondary Outcome Measures
Name Time Method Absolute Change > 1% in Breast Density