Download NSABP B-40 Add-1 (2-15

IRB Approval ______________
NSABP B-40
Southeast Cancer Control Consortium Consent Form
Addendum #1
A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with
Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic
Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel
when Administered Before AC with or without Bevacizumab and Correlative
Science Studies Attempting to Identify Predictors of High Likelihood for pCR with
Each of the Regimens
[This information was not provided in the original consent form that patients signed. It is
provided here as new information to be given to patients after local approval of
Amendment #2.]
When you joined the NSABP B-40 study, the NSABP promised to tell you about new
information that might affect your participation in the trial. The NSABP would like to
inform you of some changes to the study and some additional side effects related to the
drugs used in this study.
New information about side effects related to bevacizumab:
You were told in the original consent form you signed that the drug bevacizumab may
cause wound healing problems for patients who undergo surgery while receiving the
drug. There have also been a few reports of patients receiving bevacizumab in other
trials who developed complications with wound healing due to skin problems such as
leg ulcers. These wound healing problems have been associated with infections that
may take a long time to heal. Therefore, if you develop any skin problems, such as
open sores or wounds, tell your study doctor.
You were also told in the original consent form you signed that some patients with
cancer in the abdomen or pelvis have developed bowel perforations while receiving
bevacizumab. (A bowel perforation is an abnormal opening in the bowel wall allowing
bowel contents to spill into the abdomen.) The company that makes bevacizumab
recently reported that patients receiving bevacizumab for cancers that are not in the
abdomen and pelvis have also had bowel perforations.
In a small study for patients with advanced lung cancer, 3 out of 17 patients who were
receiving the combination of docetaxel, gemcitabine, and bevacizumab developed
bowel perforations that resulted in death. Because of these deaths, the study was
stopped. Bowel perforations have not been reported in patients receiving this same
drug combination in 2 other studies, so it is not clear whether the bowel perforations that
occurred in the lung cancer patients were related to this combination of drugs or to other
medical conditions.
Since you signed the original consent form, there have also been reports of patients
receiving bevacizumab who experienced the following side effects:
2/15/08
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Participant Initials _____
IRB Approval ______________
NSABP B-40
Southeast Cancer Control Consortium Consent Form
Addendum #1
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In addition to bowel perforation, perforation of other organs or tissues (rare,
occurring in less than 3% of patients receiving bevacizumab).
Fistula (an abnormal tube-like connection between internal organs and skin or other
tissues that are not normally connected) may occur, for example, between the
gastrointestinal tract and the skin or between the gastrointestinal tract and the
vagina. A rare type of fistula, tracheo-esophageal fistula, which is an abnormal
connection between the windpipe (trachea) and the esophagus (the tube that
connects the mouth to the stomach) has been reported. (rare, occurring in less than
3% of patients receiving bevacizumab)
High blood pressure of the blood vessels in the lungs (rare, occurring in less than
3% of patients receiving bevacizumab).
Low red blood cell count (may lead to anemia, tiredness, shortness of breath); (less
likely, occurring in 3-9% of patients receiving bevacizumab).
Allergy type symptoms like stuffy nose and sneezing (less likely, occurring in 3-9%
of patients receiving bevacizumab).
Abnormally slow bowel contraction (less likely, occurring in 3-9% of patients
receiving bevacizumab)
Bleeding from the lining of the vagina (less likely, occurring in 3-9% of patients
receiving bevacizumab)
Information about side effects related to gemcitabine and docetaxel:
You were told in the original consent form you signed that the drug docetaxel alone and
the combination of capecitabine and docetaxel may cause the side effects listed below.
However, these risks were accidentally not included in the list of risks related to the
combination of gemcitabine and docetaxel. Thus, the NSABP would like to inform you
that the risks listed below are also related to the combination of gemcitabine and
docetaxel.
 Peeling of the skin (including hands and feet); (less likely, occurring in 3-9% of
patients receiving gemcitabine and docetaxel)
 Blurred vision (less likely, occurring in 3-9% of patients receiving gemcitabine and
docetaxel)
 Heart damage (rare, occurring in less than 3% of patients receiving gemcitabine and
docetaxel)
 Gastrointestinal problems (such as bleeding, blockage, or perforation which is an
abnormal opening in the stomach or bowel); (rare, occurring in less than 3% of
patients receiving gemcitabine and docetaxel)
Information about required tissue collection following your surgery:
You were told in the original consent form you signed that small samples of the tissue
removed during your surgery would be sent to the NSABP. They now will only receive
2/15/08
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Participant Initials _____
IRB Approval ______________
NSABP B-40
Southeast Cancer Control Consortium Consent Form
Addendum #1
samples if any tumor remaining at the time of your surgery is 1 cm (about half an inch)
or larger.
Information about breast reconstruction:
You were told in the original consent form you signed that if you were randomized to
Group 1B, 2B, or 3B and you have a mastectomy, that you would not be able to have
breast reconstruction until at least 3 months after your bevacizumab is completed. If
you have not yet had your mastectomy, you may have breast reconstruction at the
same time as your mastectomy. However, if tissue expanders are used, the expander
may only be expanded slightly and only up until 2 weeks before you resume
bevacizumab. No further expansion will be performed until after you complete your
bevacizumab therapy.
If you have questions about any of this information, you should discuss them with your
study doctor _______________________ at phone # ________________________.
Signatures
I have been given this new information that was not in the original consent form.
_____________________
Date
Date
2/15/08
_______________________
Participant Signature
Signature of person conducting
the informed consent discussion
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