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Consent for Research Study
Contrast-Enhanced Breast MRI and MRS:
A Correlative Science Studies to Characterize Tumor Response
in Patients Undergoing Neoadjuvant Treatment for
Locally Advanced Breast Cancer
This research is a collaborative effort between two National Cancer Institute
(NCI) cooperative groups: Cancer and Leukemia Group B (CALGB) and the
American College of Radiology Imaging Network (ACRIN).
CALGB is recruiting participants for the neoadjuvant treatment trial and inviting
those participants to also take part in the ACRIN imaging trial.
ACRIN 6657/CALGB 150007
Purpose of Study
The main goals of this research study are:
1. To determine whether we can predict how women will
respond to certain chemotherapy treatments. This will be
done by:
• Looking for particular molecules within the breast cancer
cells and blood samples
• Determining the properties of the breast cancer cells
through use of MRI (magnetic resonance imaging) and
MRS (magnetic resonance spectroscopy)
• Observing the arrangement of the breast cancer cells
within the breast
ACRIN 6657/CALGB 150007
Purpose of Study (cont.)
2. To determine if MRI/MRS scans can be routinely used
to monitor the shrinkage of breast tumors in women
receiving chemotherapy prior to breast surgery.
Approximately 384 women will participate in this
clinical trial.
ACRIN 6657/CALGB 150007
Participation Requirements
• You will be in this study during the entire time
you are receiving treatment
• We will check with your doctor every 6
months for approximately 10 years after
treatment is completed
• Your participation is voluntary and you may
stop at any time
ACRIN 6657/CALGB 150007
Participation Requirements cont.
• Your doctor may also decide to stop your
participation in this study if:
–
–
–
–
It benefits you medically
Funding has stopped
Your condition worsens
New information becomes available
ACRIN 6657/CALGB 150007
Study Procedures
• MRI/MRS scans
– Four (4) will be performed during the study:
• Scan 1 - before you begin type 1 chemotherapy
treatment
• Scan 2 - after you begin the first cycle of type 1
chemotherapy treatment
• Scan 3 - at the completion of all chemotherapy
treatments and before surgery is performed
• Scan 4 (optional) - either before or after type 1
chemotherapy treatment
ACRIN 6657/CALGB 150007
Study Procedures cont.
• Biopsy (core needle*) and Tissue Sample
– A core needle biopsy will be done before you start
type 1 chemotherapy
– A second, optional core needle biopsy will be done
at the beginning of type 2 chemotherapy
– A biopsy will also be performed at the time of
surgery
* a core needle biopsy is a procedure in which your doctor inserts a needle into your breast
to extract a small piece of tissue
ACRIN 6657/CALGB 150007
Standard Medical Procedures
• Mammograms
– Two (2) will be performed:
• The first mammogram will be performed before you
start type 1 chemotherapy
• The second will be done after you complete all
chemotherapy treatments and before surgery
• Blood Samples
– Blood will be collected at two different time
points, both before and after type 1 chemotherapy
treatment
ACRIN 6657/CALGB 150007
Standard Medical Procedures cont.
• Ultrasound
– Your doctor will determine whether you will
have two (2) ultrasounds done before and
after all chemotherapy treatments
ACRIN 6657/CALGB 150007
Treatment Options
• If you agree to take part in this study, you and
your doctor have decided to treat your breast
cancer with chemotherapy prior to surgery
– You will receive standard chemotherapy that
includes: anthracycline (type 1) and taxane (type
2) chemotherapy drugs
• If you chose not to participate, the care you
receive will not be affected
ACRIN 6657/CALGB 150007
Patient
_______________
Neoadjuvant MRI Correlative Science Trial
Procedure Time Line
Date
Date
Date
Date
_________ _________ _________ _________
Date
Date
Date
_________
_________
_________
1-3 days after
Start of AC
Cycle 1
3
4
_________
O.R. Tissue
Specimens
Date
_________
AC Chemo dates
End AC
Cycle 4
_________
Date
Cycle 3
Date
_________
5
Cycle 2
Cycle 1
Start AC
Advocate
Call
SURGERY
Date
Mammogram
2
MRI/ MRS #3
Serum sample #2
MRI/ MRS #2
Serum sample #1
Core Biopsy #1
Optional MRI/ MRS
MRI/ MRS #1
Mammogram
1
6A
Date
_________
If Starting
TAXANE
see page 2
Patient
_______________
Neoadjuvant MRI Correlative Science Trial
Page 2, Taxane arm
Date
Date
Date
Date
_________
_________
_________
_________
Mammogram
Date
Date
Date
_________
_________
_________
_________
Cycle 4
Cycle 3
Date
Taxane Chemo dates
9T
_________
Cycle 2
Call
8T
7T
Cycle 1
Advocate
MRI/ MRS #3
Serum sample #2
Optional MRI/ MRS
Optional Core Biopsy
6T
SURGERY
Date
O.R. Tissue
Specimens
Risks Associated with Study
Participation
• If you chose to participate in this study you are at risk of side
effects. Your doctor or research associate will discuss these
with you in more detail
• The risk of side effect is associated with the following
procedures:
–
–
–
–
MRI and MRS scans
Contrast agent (Gadolinium)
Intravenous catheter placement
Biopsies
• If you are pregnant or plan to become pregnant you should not
participate in this study due to reproductive risks
ACRIN 6657/CALGB 150007
Benefits of Participation
• While this study may or may not be of direct medical
benefit to you, your participation could:
– Help determine, at a very early stage, whether patients are
having a positive/negative response to treatment
– Allow doctors to tailor treatments to specific patients
– Give doctors the ability to stop treatment and avoid the side
effects or after effects that a patient would normally incur
ACRIN 6657/CALGB 150007
Patient Confidentiality
• Every effort will be made to keep your personal information
confidential
• Confidential copies of your records will be stored in the
following locations while you are on the study:
–
–
–
–
The participating institution
American College of Radiology (ACRIN)
Center for Statistical Sciences at Brown University
Cancer and Leukemia Group B (CALGB) Statistical Center at Duke
University
• Organizations such as CALGB, Food and Drug Administration
(FDA) and National Cancer Institute (NCI) may inspect or
copy your records for quality assurance and data analysis
ACRIN 6657/CALGB 150007
Cost of Participation
• There is no additional cost to the patient for
participation in this study
• Please speak with your doctor or research
associate about specific details regarding
reimbursement, any added costs or insurance
problems
ACRIN 6657/CALGB 150007
If you have questions…
• Regarding the research study:
– Contact the study doctor or research associate
• Regarding patients’ rights:
– Ask your study doctor or research associate who
you should contact at their Institutional Review
Board (IRB)
ACRIN 6657/CALGB 150007