Modelo de consentimiento informado

Protocol BO25126 CRTN 232448
José Zorrilla Silvera, M.D.
Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano Americana
Version 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,
2011 (Agencia Médica/HS) 1
INFORMED CONSENT FORM FOR THE OPTIONAL DONATION OF FROZEN
TUMOR TISSUE
Protocol Number: BIG 4-11/BO25126/TOC4939G
Title
A randomized multicenter, double-blind, placebo-
controlled comparison of chemotherapy plus
trastuzumab plus placebo versus chemotherapy plus
trastuzumab plus pertuzumab as adjuvant therapy in
patients with operable HER2-positive primary breast
cancer
Sponsor: PRODUCTOS ROCHE Q.F.S.A
Principal Investigator
Name of the Institution
Centro de Investigación Clínica Trujillo EIRL –
Clínica Peruano Americana
Address: Av. Mansiche 810.–Trujillo – Perú
Phone number: (044) - 291520
Patient Identification Number
Patient Initials
Invitation to participate in the optional donation of frozen tumor tissue:
As a part of your treatment you recently had to undergo a surgery to remove your
HER2-positive breast cancer. You have given your consent to participate in the
APHINITY study, sponsored by F. Hoffmann-La Roche Ltd. represented in Peru
by Productos Roche Q.F.S.A., hereinafter referred as Roche, and conducted with
the collaboration of the Breast International Group (BIG, located in Belgium,
website: www.breastinternationalgroup.org), a non profit international academic
organization. For this reason, we provide you with this informed consent form.
Besides the consent you gave to participate in the APHINITY study, BIG and
ROCHE wish to request your consent to donate a tumor sample, which has been
removed by surgery and to allow it to be frozen for research purposes.
We invite you to donate this tissue so that it may be used in future scientific
researches. The tumor samples will be moved and stored in the Study Sample
Repository (i.e., biological materials bank) in Brussels, Belgium, which will be
under custody of BIG and directed by the directive committee of the APHINITY
study.

Before accepting or rejecting the request for the donation of a tumor sample, you
should understand the reasons for this optional donation and the steps to be
followed. Please, for more information about the terminology or technical
expressions or any other question or concern about the content of this document,
ask your study doctor or staff. Do not sign this form until you are satisfied with the
answers given to your questions and you are decided to give this donation
voluntarily.
This is an optional donation: your participation in APHINITY does not
oblige to donate a frozen sample of your tumor.
What will happen to my frozen tumor sample if I accept to move it to BIG?
These samples will be used in future researches and will be subject to
evaluations to detect markers that may help to researches related to several
issues such as pertuzumab and trastuzumab treatments, side effects, breast
cancer, related diseases and their diagnosis. For this purpose, several
techniques will be used.
This research may include protein analysis, ARN and non hereditary factors
(which are not genetically transmitted from a generation to the other) by using the
tumor’s ADN.
Future scientific researches on the frozen tumor sample may require the analysis
of your medical information that has been obtained as a part of the APHINITY
study. For more information, refer to the specific section on Confidentiality
Protection.
What does giving consent mean?
Once you understand what the frozen tumor sample donation is, and you are
satisfied with the answers to your questions and ready to express your will to
donate, you should give your written consent by signing this form. This process is
known as informed consent.
Who performs this optional donation procedure?
The optional donation procedure may be conducted by any of the research sites
participating in the APHINITY study and which have the necessary resources to
collect, freeze and store tumor samples until they are moved to the study Sample
Repository (i.e., biological materials bank) supervised by BIG and carried out by
Study Monitors and/or Roche’s subsidiary staff on behalf of BIG and ROCHE.
Is there any risk in the donation of a frozen tumor sample?
The sample BIG and Roche request is a residual sample; this means, a sample
that could not be used to establish your diagnosis or treatment. For this purpose,

another sample will be stored in Centro de Investigación Clínica Trujillo EIRL –
Clínica Peruano Americana and will be used for this purpose.
Is there any cost for me to participate in the study?
There are no additional costs.
Voluntary Participation:
The consent for the donation of a frozen tumor sample is voluntary and you will
have enough time to decide whether or not to donate. If you do not accept, this
decision will not affect your medical care or the benefits you currently have. At
any moment, without any reason, you will be able to request your sample to not
be used for research purposes anymore. Under no circumstances, this decision
will affect the subsequent treatment or the relation with your doctor or the staff
from Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano Americana.
If you withdraw your consent, your frozen tumor sample could be sent to Centro
de Investigación Clínica Trujillo EIRL – Clínica Peruano Americana. where you
are treated or it may be destroyed if you request so, provided that it has not been
previously used for or subject to specific processes. This is because tumor
individual samples can not be recovered once they have been processed for
laboratory analysis.
How do I benefit from donating a tumor sample?
You should understand that your frozen tumor samples are collected for future
scientific researches. This means you will not obtain any personal benefit from
your donation. In other words, the information obtained from this donation will not
be used to make decisions on diagnosis or therapies related to your personal
care.
However, we expect that this research will increase our knowledge about breast
cancer and on the way to carry out future clinical studies by using technologies
that analyze genes active during breast cancer.
This will allow us to improve the quality of treatment and, thus, to help other
patients with breast cancer in the future.
Will I be paid for participating in this study?
You will not receive any payment for your participation in this study. Reasonable
travel expenses arising as a result of your participation in this study will be
reimbursed. The study site will also be paid for the expenses to conduct this
study.
Who will be able to access the medical information related to my tumor
sample?
If you agree to donate a frozen tumor sample, your privacy will be protected at
any moment. We know that the information about you and your health is
confidential and we commit to protect the privacy of such information. All the data

collected in relation to the frozen tumor sample (personal, clinical, economic data
or those data obtained from research on the tumor) will be used pursuant to the
valid national regulations on data protection and privacy. The regulations set
forth that you should authorize us in written to use any information about your
health related to the frozen tumor sample for future scientific researches. By
signing this consent form, you give the study doctor and staff authorization to use
this information and to share it with the Sponsor (F. Hoffmann-La Roche Ltd.,
represented in Peru by Productos Roche Q.F.S.A.) and BIG. This permission
does not expire automatically on a certain date unless you decide to withdraw
your consent to use your tumor and/or your medical information.
Besides, in the context of scientific collaboration with other research groups, your
medical information and your frozen tumor samples may be shared with
researchers from other institutions/hospitals, laboratories, organizations or
private partners, which may be located in other countries or continents. However,
you will not be identified by name, address, telephone number or other
information which may lead to directly identify you (i.e., your social security
number). Your data will be coded and your identity will not be revealed to third
parties. The information related to the code will be kept in a safe place and only
study staff will be able to access to it.
Reports or publications about the scientific researches conducted on your tumor
samples will not reveal your identity either.
By signing this consent, you accept that the coded information about your frozen
tumor sample will be used in any of the following manners:
- Storage and electronic analysis to interpret the results of scientific
research
- Publication of the results obtained in the scientific research
- Shared use of your sample in researches of other universities, academic
organizations or institutions, in order to better understand the human
biology or to develop clinical studies.
- Shared use of your sample with other BIG’s members, in the country
where you receive treatment or in other countries. If the information is sent
to other country, your data will keep the same protection degree, as per
the local regulation.
- Collaboration with other investigators to use the information related to your
health and coded genomic data in secondary research projects. These
projects may be focused on the breast cancer study or not. This means
that your data may be used to study the existing differences between
several cancers. It is likely that you will not have access to the results of
this analysis.
You are entitled to ask for your personal information and to modify it if its content
is inaccurate.

Explanation: your coded personal information (that means, replacing your name
and any other data that may identify you with a code), collected to the moment
you withdraw your consent will continue to be used as a study data if appropriate
from the scientific point of view.
What will happen with my tumor sample?
Your frozen tumor sample will be stored safely in a Study Sample Repository,
labeled with a single numeric code, as per the applicable legislation, and as long
as you do not request to return it to the Centro de Investigación Clínica Trujillo
EIRL – Clínica Peruano Americana, where you receive treatment or you request
to destroy it.
The frozen tumor samples stored in the Study Sample Bank may be available in
the future for scientific investigators to improve the understanding and the breast
cancer treatment. These investigators will require an academic investigators
committee, on behalf of the medical teams participating in the APHINITY study,
to approve their scientific research. Any future scientific research using your
frozen tumor sample will only be conducted with the approval of Centro de
Investigación Clínica Trujillo EIRL – Clínica Peruano Americana.
The proposed research may lead to findings obtained, among other reasons,
thanks to your frozen tumor sample stored in the Study Sample Repository, and
the company will be entitled to claim the ownership of those findings. You will not
have any right to claim any portion of the profits that may be obtained from the
researches conducted on your frozen tumor sample. As a research participant,
you accept to renounce to all the ownership rights on findings arising from the
use of your clinical data and future researches conducted on the tumor sample.
If you agree to donate your frozen tumor sample, you will be given a copy of this
informed consent form about the optional donation of frozen tumor sample.
My signature below means that:
- I have received all the corresponding information about the optional
donation of the frozen tumor sample, I have had the chance to make
questions and enough time to think about my participation in the study
- I have been given a copy of the informed consent form about the optional
donation of the frozen tumor sample
- I accept to donate my frozen tumor sample and allow the access to my
other medical data as stated herein. I understand that all my medical data
to be used in future scientific researches will be used pursuant to the
regulations in force about data protection.
- I understand that other investigators outside F. Hoffmann-La Roche Ltd.,
represented in Peru by Productos Roche Q.F.S.A. / Breast International
Group, including other investigators who work for local or foreign

commercial companies, may conduct some of the future scientific
researches.
- My participation is completely voluntary and I have the right to withdraw
my consent at any moment without any reason. This decision will not
affect the relation with my doctor.

Patient’s print
name
Patient’s National
Identity Card No.
Patient’s
Signature
Date of Signature Time of
Signature
Witness’
print name
Witness’
National
Identity
Card No.
Witness’
Relationship to
Patient
Witness’
Signature
Date of
Signature
Time of
Signature
I, the undersigned, assigned investigator/staff member for the procedure, have
orally provided all the information corresponding to the optional donation, I have
provided a copy of the informed consent form about the optional donation of
frozen tumor tissue, I have answered all the additional concerns and I have not
coerced the patient to influence his/her decision.
Investigator/Designee’s
Signature (Print name)
National Identity
Card No. of
person
conducting
explanation of
informed consent
Signature of
person
conducting
explanation of
informed consent
Date of
Signature
Time of
Signature

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