Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

Inclusion Criteria:

• 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 menstrual cycle.
• 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.

Exclusion Criteria:

• 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 administration.
• 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