Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI) (GEMMA 2)

Bayer

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104584

91782

2009-009598-90 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  • a. patient is younger than 50 years;
  • b. patient has heterogeneously or extremely dense breasts;
  • c. 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/1.73m^2 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/1.73m^2).
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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460 participants in 1 patient group

Gadobutrol (Gadavist, BAY86-4875)

Experimental group

Description:

Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) \[0.1 ml/kg bw\] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)