An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist®) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI
- Recent histologically proven diagnosis of breast cancer after having obtained X-Ray
Mammography (XRM) of both breasts (according to American College of Radiology [ACR]
and performed no longer than 6 weeks prior to enrollment into the study) and has been
referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to
surgery of the breast.
- If female, a digital XRM is required if any of the following criteria is met:
1. patient is younger than 50 years;
2. patient has heterogeneously or extremely dense breasts;
3. is not post-menopausal (post-menopause defined as at least 12 months prior to
inclusion without menstruation).
- If female of childbearing potential, MRM should be performed on the 7-14th day of the
- Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m2 derived
from a serum creatinine result within 2 weeks prior to study enrollment.
- Is a female patient who is pregnant or lactating
- Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the
use of gadolinium-containing contrast agents.
- Has received any contrast agent within 24 hours prior to the study MRM, or is
scheduled to receive any contrast agent within 24 hours after the study MRM.
- Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial
infarction [< 14 days], unstable angina, congestive heart failure New York Heart
Association class IV) or acute stroke (< 48 hours)).
- Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the
peri-operative liver transplantation period or who has acute or chronic moderate or
severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m2).
- Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
- Has received hormone replacement therapy within 4 weeks prior to study drug
- Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24
hours following study drug application
- Has prior excisional biopsy or breast surgery less than 6 months before enrollment
and between XRM and study MRM