Clinical trial: NCT02785939
Section: Alternatives
Subsections: * NOTES FOR LOCAL INVESTIGATORS:

Official Study Title for Internet Search on
http://www.ClinicalTrials.gov  
S1400, "A Biomarker-Driven Master Protocol for Previously
Treated Squamous Cell Lung Cancer"
S1400C, "A Phase II Study of Palbociclib for Previously Treated Cell
Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell
Lung Cancer (Lung-MAP Sub-Study)" (Revised 12/1/14) (Revised 4/22/15)
(Revised11/18/15)  
What is the usual approach to my lung cancer?  
Squamous cell lung cancers make up about one-fourth of non-small cell lung cancer.
Various chemotherapy drugs have been shown to improve survival for patients with
advanced squamous lung cancer. Most patients will be treated at first with cisplatin or
carboplatin in combination with a second chemotherapy drug such as gemcitabine,
paclitaxel, docetaxel, or vinorelbine. In addition, an immunotherapy drug called nivolumab
was recently FDA approved for patients with squamous lung cancer who previously
received chemotherapy. (Paragraph Revised 4/22/15)  
What are my other choices if I do not take part in this study?  
Your other choices may include:  
You may choose to have the usual approach described above
You may choose to take part in a different study, if one is available
You may choose to get comfort care, also called palliative care. This type of care
helps reduce pain, tiredness, appetite problems and other problems caused by the
cancer. It does not treat the cancer directly, but instead tries to improve how you
feel. Comfort care tries to keep you as active and comfortable as possible.  
You may choose to have the usual approach described above  
You may choose to take part in a different study, if one is available  
You may choose to get comfort care, also called palliative care. This type of care
helps reduce pain, tiredness, appetite problems and other problems caused by the
cancer. It does not treat the cancer directly, but instead tries to improve how you
feel. Comfort care tries to keep you as active and comfortable as possible.  
Talk to your doctor about your choices before you decide if you will take part in this study.  
Why is this study being done?  
There are several investigational treatments that are being tested in various sub-studies as
part of this study. You will have already received the information on your biomarker
testing. You have been assigned to this treatment study because your tumor sample had
changes in genes and proteins called the Cell Cycle Gene Alteration biomarker. The
purpose of this sub-study is to look at the effects (good and bad) of palbociclib. Palbociclib
is investigational for this study. Palbociclib may or may not shrink your cancer and it
could also cause side effects. (Paragraph Revised11/18/15)
Clinical trial: NCT02785939
Section: Confidentiality
Subsections: ||Who will see my medical information?|HOW WILL INFORMATION ABOUT ME BE KEPT PRIVATE?||

NOTES FOR LOCAL INSTITUTION INFORMED CONSENT AUTHORS:  
This model informed consent form has been reviewed by the DCTD/NCI and is the official
consent document for this study. Local IRB changes to this document are allowed. (Institutions
should attempt to use sections of this document that are in bold type in their entirety.) Editorial
changes to these sections may be made as long as they do not change information or intent. If
the institutional IRB insists on making additions, deletions, or more substantive modifications to
the risks or alternatives sections, they may be justified in writing by the investigator and
approved by the IRB. Under these circumstances, the revised language, justification and a copy
of the IRB minutes must be forwarded to the SWOG Operations Office for approval before a
patient may be registered to this study.  
Please particularly note that the questions related to banking of specimens for future study are
in bolded type and may not be changed in any way without prior approval from the SWOG
Operations Office.  
Readability Statistics:
Flesch Reading Ease
59.3
(targeted above 55)
Flesch-Kincaid Grade Level
9.2
(targeted below 8.5)  
Instructions and examples for informed consent authors are in [italics].
A blank line,
,
indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.
The term "study doctor" has been used throughout the model because the local
investigator for a cancer treatment trial is a physician. If this model is used for a trial in
which the local investigator is not a physician, another appropriate term should be used
instead of "study doctor".
The dates of protocol updates in the header and in the text of the consent is for reference
to this model only and should not be included in the informed consent form given to the
prospective research participant.
The local informed consent must state which parties may inspect the research records.
This includes the NCI, the drug manufacturer for investigational studies, any companies
or grantors that are providing study support (these will be listed in the protocol's model
informed consent form) and SWOG.  
Instructions and examples for informed consent authors are in [italics].  
A blank line,
,
indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.  
The term "study doctor" has been used throughout the model because the local
investigator for a cancer treatment trial is a physician. If this model is used for a trial in
which the local investigator is not a physician, another appropriate term should be used
instead of "study doctor".  
The dates of protocol updates in the header and in the text of the consent is for reference
to this model only and should not be included in the informed consent form given to the
prospective research participant.  
The local informed consent must state which parties may inspect the research records.
This includes the NCI, the drug manufacturer for investigational studies, any companies
or grantors that are providing study support (these will be listed in the protocol's model
informed consent form) and SWOG.

Page 2  
"SWOG" must be listed as one of the parties that may inspect the research records in all
protocol consent forms for which patient registration is being credited to SWOG. This
includes consent forms for studies where all patients are registered directly through the
SWOG Data Operations Office, all intergroup studies for which the registration is being
credited to SWOG (whether the registration is through the SWOG Data Operations
Office or directly through the other group), as well as consent forms for studies where
patients are registered via CTSU and the registration is credited to SWOG.  
When changes to the protocol require revision of the informed consent document, the
IRB should have a system that identifies the revised consent document, in order to
preclude continued use of the older version and to identify file copies. An appropriate
method to identify the current version of the consent is for the IRB to stamp the final
copy of the consent document with the approval date. The stamped consent document is
then photocopied for use. Other systems of identifying the current version of the consent
such as adding a version or approval date are allowed as long as it is possible to
determine during an audit that the patient signed the most current version of the consent
form.

Your privacy is very important to us and the researchers will make every effort to protect it.
Your information may be given out if required by law. For example, certain states require
doctors to report to health boards if they find a disease like tuberculosis. However, the
researchers will do their best to make sure that any information that is released will not identify
you. Some of your health information, and/or information about your specimen, from this study
will be kept in a central database for research. Your name or contact information will not be put
in the database.  
There are organizations that may inspect your records. These organizations are required to make
sure your information is kept private, unless required by law to provide information. Some of
these organizations are:  
The study sponsor, SWOG, and the drug company supporting the treatment sub-study
you are on.
The Institutional Review Board, IRB, is a group of people who review the research with
the goal of protecting the people who take part in the study.
The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) in the
U.S., and similar ones if other countries are involved in the study. (Revised 12/1/14)
TRIAD-Your medical images with clinical study data (e.g., the treatment Group you are
assigned to, etc.) will be transferred to the Ohio State University in Columbus, Ohio.
Your medical images will be reviewed by physicians at this organization as part of the
study analysis for this trial. In addition, information gained from this study may be used
in the future for additional research and only that data would be provided to other
scientist for future research. Your name, and any other information that could be used to
identify you personally, will not be included. (Added 12/1/14)  
The study sponsor, SWOG, and the drug company supporting the treatment sub-study
you are on.  
The Institutional Review Board, IRB, is a group of people who review the research with
the goal of protecting the people who take part in the study.  
The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) in the
U.S., and similar ones if other countries are involved in the study. (Revised 12/1/14)  
TRIAD-Your medical images with clinical study data (e.g., the treatment Group you are
assigned to, etc.) will be transferred to the Ohio State University in Columbus, Ohio.
Your medical images will be reviewed by physicians at this organization as part of the
study analysis for this trial. In addition, information gained from this study may be used
in the future for additional research and only that data would be provided to other
scientist for future research. Your name, and any other information that could be used to
identify you personally, will not be included. (Added 12/1/14)  
Where can I get more information?  
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or
general information about cancer. You may also call the NCI Cancer Information Service to get
the same information at: 1-800-4-CANCER (1-800-422-6237).  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by U.S. Law. This Web site will not include information that can identify you. At
most, the Web site will include a summary of the results. You can search this Web site at
any time.  
[Note to Informed Consent Authors: The above paragraph complies with the new FDA
regulation found at 21CFR50.25 (c) and must be included verbatim in all informed consent
documents. The text in this paragraph cannot be revised (Added 12/1/14)

Your privacy is very important to the researchers and they will make every effort to protect it.
Here are just a few of the steps they will take:  
1) When your samples are sent to the researchers, no information identifying you (such
as your name) will be sent. Samples will be identified by a unique code only.
2) The list that links the unique code to your name will be kept separate from your
sample and health information. Any Biobank and SWOG staff with access to the list
must sign an agreement to keep your identity confidential.
3) Researchers to whom SWOG sends your sample and information will not know who
you are. They must also sign an agreement that they will not try to find out who you
are.
4) Information that identifies you will not be given to anyone, unless required by law.
5) If research results are published, your name and other personal information will not
be used.  
1) When your samples are sent to the researchers, no information identifying you (such
as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your
sample and health information. Any Biobank and SWOG staff with access to the list
must sign an agreement to keep your identity confidential.  
3) Researchers to whom SWOG sends your sample and information will not know who
you are. They must also sign an agreement that they will not try to find out who you
are.  
4) Information that identifies you will not be given to anyone, unless required by law.  
5) If research results are published, your name and other personal information will not
be used.  
(Deleted 12/1/14)

|    |                                                                                                                                                                                                                                                                                                                                                                                                             |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) | Qualified researchers can submit a request to use the materials stored in the Biobanks. A science committee at the clinical trials organization, and/or the National Cancer Institute, will review each request. There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you. |
| 3) | Neither you nor your study doctor will be notified when research will be conducted or given reports or other information about any research that is done using your samples.                                                                                                                                                                                                                                |
| 4) | Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.                                                                                                                                                                                        |



|    |                                                                                                                                                                                                                               |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    |                                                                                                                                                                                                                               |
| 1) | When your samples are sent to the researchers, no information identifying you (such as your name) will be sent. Samples will be identified by a unique code only.                                                             |
| 2) | The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and SWOG staff with access to the list must sign an agreement to keep your identity confidential. |
| 3) | Researchers to whom SWOG sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.                                                        |
| 4) | Information that identifies you will not be given to anyone, unless required by law. If research results are published, your name and other personal information will not be used.                                            |
| 5) |                                                                                                                                                                                                                               |
Clinical trial: NCT02785939
Section: Duration of Study Involvement
Subsections: How long will I be in this study?

You will be on treatment until your disease clearly worsens. After you are finished taking study
treatment, the study doctor will continue to watch you for side effects and follow your condition
for 3 years from the time you started treatment. (Revised11/18/15) At the follow up visits you
will have a physical exam, blood tests, and scans. Your doctor may give you other tests or
procedures if they think they are needed.  
Should your disease worsen, you have the option to participate in a different sub-study. As
before, the new sub-study that you will be offered will depend on a combination of the results of
the previous testing done on your tumor sample and the sub-studies available. If your tumor has
Clinical trial: NCT02785939
Section: Participant's Rights
Subsections: * NOTES FOR LOCAL INVESTIGATORS:

The goal of the informed consent process is to provide people with sufficient information
for making informed choices. The informed consent form provides a summary of the
clinical study and the individual's rights as a research participant. It serves as a starting
point for the necessary exchange of information between the investigator and potential
research participant. This model for the informed consent form is only one part of the
larger process of informed consent. For more information about informed consent, review
the "Recommendations for the Development of Informed Consent Documents for Cancer
Clinical Trials" prepared by the Comprehensive Working Group on Informed Consent in
Cancer Clinical Trials for the National Cancer Institute. The Web site address for this
document is http://cancer.gov/clinicaltrials/understanding/simplification-of-informed-
consent-docs/
A blank line,
, indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.
Suggestion for Local Investigators: An NCI pamphlet explaining clinical trials is
available for your patients. The pamphlet is titled: "Taking Part in Cancer Treatment
Research Studies". This pamphlet may be ordered on the NCI Web site at
https://cissecure.nci.nih.gov/ncipubs or call 1-800-4- CANCER (1-800-422-6237) to
request a free copy.
Optional feature for Local Investigators: Reference and attach drug sheets,
pharmaceutical information for the public, or other material on risks. Check with your
local IRB regarding review of additional materials.  
The goal of the informed consent process is to provide people with sufficient information
for making informed choices. The informed consent form provides a summary of the
clinical study and the individual's rights as a research participant. It serves as a starting
point for the necessary exchange of information between the investigator and potential
research participant. This model for the informed consent form is only one part of the
larger process of informed consent. For more information about informed consent, review
the "Recommendations for the Development of Informed Consent Documents for Cancer
Clinical Trials" prepared by the Comprehensive Working Group on Informed Consent in
Cancer Clinical Trials for the National Cancer Institute. The Web site address for this
document is http://cancer.gov/clinicaltrials/understanding/simplification-of-informed-
consent-docs/  
A blank line,
, indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.  
Suggestion for Local Investigators: An NCI pamphlet explaining clinical trials is
available for your patients. The pamphlet is titled: "Taking Part in Cancer Treatment
Research Studies". This pamphlet may be ordered on the NCI Web site at
https://cissecure.nci.nih.gov/ncipubs or call 1-800-4- CANCER (1-800-422-6237) to
request a free copy.  
Optional feature for Local Investigators: Reference and attach drug sheets,
pharmaceutical information for the public, or other material on risks. Check with your
local IRB regarding review of additional materials.  
* These notes for authors and investigators are instructional and should not be included in the
informed consent form given to the prospective research participant.
Clinical trial: NCT02785939
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What possible risks can I expect from taking part in this study?|What possible risks can I expect from taking part in this study?|COMMON, SOME MAY BE SERIOUS|COMMON, SOME MAY BE SERIOUS|RARE, AND SERIOUS|What are the costs of taking part in this study?|What happens if I am injured or hurt because I took part in this study?|WHAT ARE THE POSSIBLE RISKS?|WHAT ARE THE POSSIBLE RISKS?|WHAT ARE THE POSSIBLE BENEFITS?

If you choose to take part in this study, there is a risk that you may:  
Lose time at work or home and spend more time in the hospital or doctor's office
than usual
Be asked sensitive or private questions which you normally do not discuss  
Lose time at work or home and spend more time in the hospital or doctor's office
than usual  
Be asked sensitive or private questions which you normally do not discuss

Page 6  
Treatment Consent  
The treatment used in this study may affect how different parts of your body work such as
your liver, kidneys, heart, and blood. The study doctor will be testing your blood and will
let you know if changes occur that may affect your health.  
There is also a risk that you could have side effects.  
Here are important points about side effects:  
The study doctors do not know who will or will not have side effects.
Some side effects may go away soon, some may last a long time, or some may never
go away.
Some side effects may interfere with your ability to have children.
Some side effects may be serious and may even result in death.  
The study doctors do not know who will or will not have side effects.  
Some side effects may go away soon, some may last a long time, or some may never
go away.  
Some side effects may interfere with your ability to have children.  
Some side effects may be serious and may even result in death.  
Here are important points about how you and the study doctor can make side effects less of
a problem:  
Tell the study doctor if you notice or feel anything different so they can see if you
are having a side effect.  
The study doctor may be able to treat some side effects.  
The study doctor may adjust the study drugs to try to reduce side effects.  
The tables provided below show the most common and the most serious side effects that
researchers know about related to palbociclib. There might be other side effects that
researchers do not yet know about. If important new side effects are found, the study
doctor will discuss these with you.

In 100 people receiving palbociclib, more than 20 and up to 100 may have:  
Anemia which may require blood transfusion
Nausea
Tiredness
Bruising, bleeding
Infection, especially when white blood cell count is low  
Anemia which may require blood transfusion  
Nausea  
Tiredness  
Bruising, bleeding  
Infection, especially when white blood cell count is low

In 100 people receiving palbociclib, from 4 to 20 may have: (Table Replaced 11/18/15)
(Table Replaced 7/19/16)  
Dry eye, skin
Watering eyes
Constipation, diarrhea, vomiting
Sores in the mouth which may cause difficulty swallowing
Fever
Loss of appetite
Changes in taste
Headache
Nose bleed
Hair loss, rash  
Dry eye, skin  
Watering eyes  
Constipation, diarrhea, vomiting  
Sores in the mouth which may cause difficulty swallowing  
Fever  
Loss of appetite  
Changes in taste  
Headache  
Nose bleed  
Hair loss, rash

In 100 people receiving palbociclib, 3 or fewer may have: (Table Added 7/19/16)  
Blood clot which may cause swelling, pain, shortness of breath  
Let your study doctor know of any questions you have about possible side effects. You can ask
the study doctor questions about side effects at any time.  
Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study
as the drugs used in this study could be very damaging to an unborn baby. Women and men who
receive palbociclib should use effective contraception during the period of the trial and for at
least 90 days after completion of treatment. Check with the study doctor about what types of
birth control, or pregnancy prevention, to use while in this study.  
What possible benefits can I expect from taking part in this study?  
It is not possible to know at this time if the study drug/study approach is better than the usual
approach, SO this study may or may not help you. This study will help researchers learn things
that will help people in the future.  
Can I stop taking part in this study?  
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let
the study doctor know as soon as possible SO you can stop safely. If you stop, you can decide
whether or not to let the study doctor continue to provide your medical information to the
organization running the study.  
The study doctor will tell you about new information or changes in the study that may affect
your health or your willingness to continue in the study.

The palbociclib will be supplied at no charge while you take part in this study. The cost of
getting the palbociclib ready and giving it to you is not paid by the study sponsor SO you or your
insurance company may have to pay for this. It is possible that the palbociclib may not continue
to be supplied while you are on the study. Although not likely, if this occurs, your study doctor
will talk to you about your options.  
You and/or your health plan/insurance company will need to pay for all of the other costs of
treating your cancer while in this study, including the cost of tests, procedures, or medicines to
manage any side effects, unless you are told that certain tests are supplied at no charge. Before
you decide to be in the study, you should check with your health plan or insurance company to
find out exactly what they will pay for.  
You will not be paid for taking part in this study.

If you are injured or hurt as a result of taking part in this study and need medical treatment,
please tell your study doctor. The study sponsors will not offer to pay for medical treatment for
injury. Your insurance company may not be willing to pay for study-related injury. If you have
no insurance, you would be responsible for any costs.  
If you feel this injury was a result of medical error, you keep all your legal rights to receive
payment for this even though you are in a study.

1)
There is a risk that someone could get access to the personal information in your
medical records or other information researchers have stored about you.
2) There is a risk that someone could trace the information in a central database back to
you. Even without your name or other identifiers, your genetic information is unique
to you. The researchers believe the chance that someone will identify you is very
small, but the risk may change in the future as people come up with new ways of
tracing information.
3) In some cases, this information could be used to make it harder for you to get or keep
a job or insurance. There are laws against the misuse of genetic information, but they
may not give full protection. There can also be a risk in knowing genetic information.  
1)
There is a risk that someone could get access to the personal information in your
medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to
you. Even without your name or other identifiers, your genetic information is unique
to you. The researchers believe the chance that someone will identify you is very
small, but the risk may change in the future as people come up with new ways of
tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep
a job or insurance. There are laws against the misuse of genetic information, but they
may not give full protection. There can also be a risk in knowing genetic information.

Page 12  
The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA,
was passed by Congress to protect Americans from such discrimination.  
The law prevents discrimination from health insurers and employers. This law does
not cover life insurance, disability insurance and long-term care insurance. New
health information about inherited traits that might affect you or your blood relatives
could be found during a study. The researchers believe the chance these things will
happen is very small, but cannot promise that they will not occur.

You will not benefit from taking part.  
The researchers, using the samples from you and others, might make discoveries that could help
people in the future.
Clinical trial: NCT02785939
Section: Procedures
Subsections: What are the study groups?|How long will I be in this study?|What extra tests and procedures will I have if I take part in this study?|Who can answer my questions about this study?|WHAT IS INVOLVED?|WHAT IS INVOLVED?|

You have been assigned to this sub-study because your tumor sample had the CDK4/6
biomarker. This sub-study is a single arm study. (Revised11/18/15)  
The study drug palbociclib is taken by mouth. Palbociclib should be taken with food. Capsules
should be taken whole and not chewed up prior to swallowing. (Revised11/18/15)  
The target treatment on this study is described in the table below.  
(Revised11/18/15)  
Another way to find out what may happen to you during the study is to read the chart below.
Start reading at the top of the chart and read down, following the arrows.  
Screening/Pre-Screening Registration  
(Revised 12/1/14) (Revised 4/22/15) (Revised11/18/15)

Page 5  
multiple biomarkers with sub-studies designed for them, you will be assigned to one of the sub-
studies randomly (by chance). There is a sub-study available if your tumor does not have any
additional biomarkers being tested or you were not eligible to participate in other sub-studies. If
you do not have any of the biomarkers being tested and have had prior immunotherapy treatment
(such as nivolumab) you will not be eligible. (Paragraph Added 7/19/16)

Most of the exams, tests, and procedures you will have are part of the usual approach for your
cancer. However, there are some extra exams, tests, and/or procedures that you will need to have
if you take part in this study. (Added11/18/15)  
Before you begin the study:  
Brain CT or MRI (to check if your cancer may have spread to your brain)
EKG (to check your heart)
Blood tests to assess blood sugar levels (Added 12/1/14) revised11/18/15)  
Brain CT or MRI (to check if your cancer may have spread to your brain)  
EKG (to check your heart)  
Blood tests to assess blood sugar levels (Added 12/1/14) revised11/18/15)  
You will have a CT or MRI done before you begin the study and then approximately every 6
weeks until your disease worsens. (Added11/18/15) Your doctor will review the CT scans or
other radiographic scans done to check on your tumors on a regular basis. These scans will also
be sent to a central location for review. This central review is part of a total study analysis only.
Information of your scans from the central review will not be sent back to you or your doctor.  
If the exams, tests, and procedures show that you can take part in the study, and you choose to
take part, then you will need the following extra tests. They are not part of the usual approach
for your type of cancer. (Added1 1/18/15)  
During the study: (Revised11/18/15)  
EKG (to check heart)
Blood tests to assess blood sugar levels  
EKG (to check heart)  
Blood tests to assess blood sugar levels  
You will have your blood monitored to check your blood sugar while you are on this study.
(Revised 12/1/14) (Revisedl 1/18/15) Your blood sugar will be checked before you begin the
study and approximately on Day 1 of every third cycle. (Added 12/1/14) You will have an EKG
to check your heart before you begin the study and approximately on Week 7.  
Neither you nor your health care plan/insurance carrier will be billed for the following tests for
this study: (Added 4/22/15) (Section Revised11/18/15  
Blood tests to assess blood sugar (Hb1Ac tests)
EKG to check your heart  
Blood tests to assess blood sugar (Hb1Ac tests)  
EKG to check your heart

You can talk to the study doctor about any questions or concerns you have about this study or to
report side effects or injuries. Contact the study doctor
(insert name of
study doctor[s] at
(insert telephone number).

If you agree to take part, here is what will happen next:  
1) Your specimens may be stored in the Biobank, along with samples from other people
who take part. These specimens may include:

Page 11  
(Deleted 4/22/15)
About 2 tablespoons of blood will be collected from a vein in your arm (at the
same time as other study blood tests) on Weeks 5, 7, 9, and again if your
cancer gets worse. (Revised 4/22/15) (Revised 7/19/16)
(Deleted11/18/15)
A sample of tissue will be collected from an optional extra biopsy if your
cancer gets worse after treatment on this study. Common side effects of a
biopsy are a small amount of bleeding at the time of the procedure, pain and
bruising at the biopsy site, which can be treated with regular pain medications.
Rarely, an infection can occur. You will sign a separate consent form before
the biopsy is taken. This will be a standard surgical consent form from the
institution where the biopsy procedure takes place. Rarely, patients may
experience partial lung collapse that may require a chest tube or even a
breathing machine. The samples will be kept until they are used up. (Added
7/19/16)  
(Deleted 4/22/15)  
About 2 tablespoons of blood will be collected from a vein in your arm (at the
same time as other study blood tests) on Weeks 5, 7, 9, and again if your
cancer gets worse. (Revised 4/22/15) (Revised 7/19/16)  
(Deleted11/18/15)  
A sample of tissue will be collected from an optional extra biopsy if your
cancer gets worse after treatment on this study. Common side effects of a
biopsy are a small amount of bleeding at the time of the procedure, pain and
bruising at the biopsy site, which can be treated with regular pain medications.
Rarely, an infection can occur. You will sign a separate consent form before
the biopsy is taken. This will be a standard surgical consent form from the
institution where the biopsy procedure takes place. Rarely, patients may
experience partial lung collapse that may require a chest tube or even a
breathing machine. The samples will be kept until they are used up. (Added
7/19/16)  
(Deleted 7/19/16)  
2)
Qualified researchers can submit a request to use the materials stored in the
Biobanks. A science committee at the clinical trials organization, and/or the
National Cancer Institute, will review each request. There will also be an ethics
review to ensure that the request is necessary and proper. Researchers will not be
given your name or any other information that could directly identify you.
3)
Neither you nor your study doctor will be notified when research will be
conducted or given reports or other information about any research that is done
using your samples.
4)
Some of your genetic and health information may be placed in central databases
that may be public, along with information from many other people. Information
that could directly identify you will not be included.  
2)
Qualified researchers can submit a request to use the materials stored in the
Biobanks. A science committee at the clinical trials organization, and/or the
National Cancer Institute, will review each request. There will also be an ethics
review to ensure that the request is necessary and proper. Researchers will not be
given your name or any other information that could directly identify you.  
3)
Neither you nor your study doctor will be notified when research will be
conducted or given reports or other information about any research that is done
using your samples.  
4)
Some of your genetic and health information may be placed in central databases
that may be public, along with information from many other people. Information
that could directly identify you will not be included.

|   Arm  | Drug        | How often is it given?             | How is it given?    | What days is it given on?    | What is the cycle duration?    |
|--------|-------------|------------------------------------|---------------------|------------------------------|--------------------------------|
|     1  | Palbociclib | Daily for 3 weeks, then 1 week off | By mouth            | Days 1-21                    | 28 days                        |

(Revised11/18/15)
Clinical trial: NCT02785939
Section: Purpose of Research
Subsections: 1. Optional Additional Biopsy and Optional Sample Collections for Laboratory Studies and/or Biobanking for Possible Future Studies

Researchers are trying to learn more about cancer, diabetes, and other health problems. Much of
this research is done using samples from your tissue, blood, urine, or other fluids. Through these
studies, researchers hope to find new ways to prevent, detect, treat, or cure health problems.
Some of these studies may be about genes. Genes carry information about features that are found
in you and in people who are related to you. Researchers are interested in the way that genes
affect how your body responds to treatment.  
If you choose to take part in this part of the study, the researchers would also like to ask your
permission to store and use your samples and health information for medical research. The
research that may be done is unknown at this time. Storing samples for future studies is called
"biobanking". The Biobank is being run by SWOG and supported by the National Cancer
Institute.
Clinical trial: NCT02785939
Section: Voluntary Participation
Subsections: * NOTES FOR LOCAL INVESTIGATORS:|What are my rights in this study?|This section is about optional studies you can choose to take part in|WHAT IF I HAVE MORE QUESTIONS?

There will be about 40 patients taking part in this study. (Revised 4/22/15) (Revised11/18/15)

Taking part in this study is your choice. No matter what decision you make, and even if your
decision changes, there will be no penalty to you. You will not lose medical care or any legal
rights.  
For questions about your rights while in this study, call the
(insert
name of center) Institutional Review Board at
(insert telephone number).
(Note to Local Investigator: Contact information for patient representatives or other individuals
at a local institution who are not on the IRB or research team but take calls regarding clinical
trial questions can also be listed here.)

This part of the consent form is about optional studies that you can choose to take part in. You
will not get health benefits from any of these studies. The researchers leading this optional study
hope the results will help other people with cancer in the future.  
The results will not be added to your medical records, nor will you or your study doctor know
the results.  
You will not be billed for these optional studies. You can still take part in the main study even if
you say 'no' to any or all of these studies. If you sign up for but cannot complete any of the
studies for any reason, you can still take part in the main study.  
Circle your choice of "yes" or "no" for each of the following studies.  
(Deleted 12/1/14)

If you have questions about the use of your samples for research, contact the study doctor,
,
(insert name of study doctor for main trial), at
(insert telephone number of study doctor for main trial).  
Please circle your answer to show whether or not you would like to take part in each option:  
SAMPLES FOR FUTURE RESEARCH STUDIES:  
1.
My tumor tissue and related information may be kept in a Biobank for use in future
health research.
YES
NO
2.
My blood samples and related information may be kept in a Biobank for use in
future health research.
YES
NO
(Revised 4/22/15)  
1.
My tumor tissue and related information may be kept in a Biobank for use in future
health research.  
YES
NO  
2.
My blood samples and related information may be kept in a Biobank for use in
future health research.  
YES
NO
(Revised 4/22/15)  
This is the end of the section about optional studies.  
My Signature Agreeing to Take Part in the Main Study  
I have read this consent form or had it read to me. I have discussed it with the study doctor and
my questions have been answered. I will be given a signed copy of this form. I agree to take part
in the main study and any additional studies where I circled 'yes'.  
Participant's signature (Deleted 12/1/14)  
Date of signature  
close
Clinical trial: NCT02785939
Section: Withdrawal from Study
Subsections: RARE, AND SERIOUS|WHAT IF I CHANGE MY MIND?

Page 8  
The study doctor may take you out of the study:  
If your health changes and the study is no longer in your best interest
If new information becomes available
If you do not follow the study rules
If the study is stopped by the sponsor, IRB or FDA.  
If your health changes and the study is no longer in your best interest  
If new information becomes available  
If you do not follow the study rules  
If the study is stopped by the sponsor, IRB or FDA.

If you decide you no longer want your samples to be used, you can call the study doctor,
,
(insert name of study doctor for main trial) at
(insert telephone number of study doctor for main trial) who will
let the researchers know. Then, any sample that remains in the bank will no longer be used.
Samples or related information that have already been given to or used by researchers will not be
returned.