Clinical trial: NCT00694577
Section: Alternatives
Subsections: What Other Options Are There?

Taking part in this study is voluntary. Instead of being in this study, you have these options:  
- Conventional radiation treatment.  
- Mastectomy (as an alternative to breast-preserving surgery and radiotherapy). - Other investigational treatments - No anti-cancer therapy at this time, with supportive care.
Please discuss these and other options with your study doctor.
Clinical trial: NCT00694577
Section: Confidentiality
Subsections: What About Confidentiality?|Privacy Of Protected Health Information|3. Who Will Use Or Share Protected Health Information About Me?

We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data. Medical information created by this study may become part of your hospital medical record. Information that does not become part of your medical record will be stored in your study file. It may also become part of a DF/HCC research database called CORIS. Information contained in your records is used by study staff. There may be times when we are required by law to share your information. In those cases, we do not need your permission. The results of this study may be published. You will not be identified in any publication without your permission.

Federal law requires Dana Farber/Harvard Cancer Center (DF/HCC) and its affiliated researchers, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past, present, and future physical and mental health an conditions ("protected health information"). If you enroll in the research described in this consent form, your "protected health information" will be used and shared with others as explained below.  
1. What protected health information about me will be used or shared with others during this research?  
- Existing medical records - New health information created from study-related tests, procedures, visits, and/or questionnaires 2. **Why will protected information about me be used or shared with others?**
The main reasons include:
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| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02
- To conduct and oversee the research described earlier in this form;
- To ensure the research meets legal, institutional, and accreditation requirements; and
- To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm)
- Other reasons may include for treatment, payment, or health care operations. For example, some medical information produced by this study may become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for Use and Sharing of Protected Health Information.)

- DF/HCC and its affiliated researchers and entities participating in the research will use and share your protected health information. In addition, the DF/HCC review board that oversees the research at DF/HCC and its affiliated staff who have a need to access this information to carry out their responsibilities (for example, oversight, quality improvement, and billing) will be able to use and share your protected health information.  
4. With whom outside of DF/HCC **may my protected health information be shared?**  
  
All reasonable efforts will be made to protect the confidentiality of your protected health information, which may be shared with the following others for the reasons noted above:
- Outside individuals or entities that have a need to access this information to perform functions on behalf of DF/HCC and its affiliates (for example, data storage companies, insurers, or legal advisors).  
- The sponsor(s) of the study, its subcontractors, and its agents: 2003 Avon Pilot Grant Awardee
- Other researchers and medical centers participating in this research, if applicable
- Federal and state agencies (for example, the Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies if required by law and/or necessary for oversight purposes.  
- Hospital accrediting agencies
- A data safety monitoring board organized to oversee this research, if applicable  
| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02 Some who may receive your protected health information may not have to satisfy the privacy rules and requirements. They, in fact, may share your information with others without your permission.  
5. **For how long will protected health information about me be used or shared with**
others?  
- There is no scheduled date at which your protected health information that is being used or shared for this research will be destroyed, because research is an ongoing process. Research information may be analyzed and re-analyzed in light of scientific and medical advances, or reviewed for quality assurance, oversight or other purposes.
Clinical trial: NCT00694577
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

You will receive radiation treatments on this study for only 1 week. After your radiation, followup office visits will be initially one to two visits at 3-9 weeks, every 6 months (+/- 2 months) for five years, then once a year (+/- 3 months) for the next five years.  
The study doctor may decide to take you off this study without your consent for any of the following reasons:
- Discontinuation of this study treatment is felt to be in your best medical interest
- You are unable to follow the study plan
- Your disease worsens - You experience unacceptable and/or harmful side effects
- If you are a woman and become pregnant You may choose not to take part in this study. If you decide to enroll on this study, you can stop participating at any time. Choosing to not participate or leaving the study will not result in any Page 4 of 13  
  
  
| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02 penalty or loss of benefits, for example medical care, to which you are entitled. If you do decide to stop participating in the study, we encourage you to discuss your decision with your doctor. New findings developed during the course of this research, which may relate to your willingness to continue participation, will be provided to you by your study doctor.
Clinical trial: NCT00694577
Section: Participant's Rights
Subsections: 6. Statement Of Privacy Rights:

- You have the right to withdraw you permission for the researchers and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. If you withdraw your permission, you must do so in writing by contacting the researcher listed as the Study Contact.  
- You have the right to choose not to sign this form. If you decide not to sign this form, you cannot participate in this research study. However, refusing to sign will not affect your present or future care and will not cause any penalty or loss of benefits to which you are otherwise entitled.  
- You have the right to request access to your protected health information that is used or shared during this research and that is related to your treatment or payment for your treatment, but you may access this information only after the study is completed. To request this information, please contact the researcher listed under Study Contacts on the consent form.
Clinical trial: NCT00694577
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?|Less Likely|Rarely|What Happens If I Am Injured Or Sick Because I Took Part In This Research Study?

While on this study, you are at risk for the side effects described below. Since this radiation procedure is investigational, there may also be other side effects that we cannot predict. Your study doctor can prescribe drugs to make some of these side effects less serious and make you more comfortable. A significant risk to taking part in this study is the small likelihood of receiving a dose of a radiation that is not fully effective in helping to treat your disease. This means that you may spend time and experience side effects undergoing radiation that does not provide you with the equivalent health-related benefits of standard radiation treatments. Other less common or unexpected side effects may also develop and may be irreversible. This intervention has not yet been proven safe and therefore, may potentially result in death (unlikely). During your therapy you will be monitored closely for potential side effects. You are expected to report to the study doctor(s) any adverse sign(s) or symptom(s) which may develop while you are on this study. For your safety, please disclose to the study doctor all of your present and past diseases and known allergies. It is important that you share with the study doctor any prescription and/or over-the-counter drugs, herbal preparations and nutritional supplements you are taking. During the research study, you will be notified of newly discovered side effects or significant findings, which may affect your health or willingness to participate. You may be asked to sign a new consent form that shows that you have been informed of new information relating to this research study.

- Peeling of the skin, like that from a sunburn - Permanent discoloration of the skin
- Hardness of the treated area which may include retraction of the breast (similar to a dent)
- Damage to fat cells in the breast that cause a red, swollen, or tender area in the breast (These damaged cells can look/feel like a lump and a biopsy may be needed which may be immediate or delayed.) (fat necrosis)
- Infection, which may be immediate or delayed and may develop as breast redness and/or pain
(cellulitis)
- Small visible blood vessels on the skin surface over the treated area (telangiectasia) - Poor cosmetic outcome due to fat and/or skin necrosis which may require surgery

- Nausea
- Decreased appetite
- Inflammation in the lung under the treated breast, usually months after the radiotherapy course. Although this is usually mild, sometimes medication or hospitalization may be needed to treat this reaction. This reaction does not seem to cause any lasting damage to lung functioning, although rarely it is possible that it might do so.  
- Fractures of the ribs. These usually heal slowly. - Damage to the heart muscles or coronary arteries years after treatment which might very rarely cause a heart attack or other major problems.  
- Severe infection that may develop as redness, pain, or a collection of infected cells (abscess) - Severe scar tissue caused by infection or damage to the fat cells and surrounding tissue (fat necrosis and severe fibrosis)
- Breast pain in the treated breast that may come early or late and last for an extended period of time or permanently
- Delayed healing following a biopsy or fine needle aspiration (FNA) in a previously treated breast with PBI, which might cause blackened skin (skin necrosis)
- Cause new cancers to appear in the treated breast years later - Cause new cancers to appear in the radiation field years later. This includes the breast, soft tissue, and lungs.  
When the left breast is treated (but not when the right breast is treated), subjects may very rarely develop inflammation of the membranes around the heart or the heart itself months after radiation therapy. This causes discomfort.  
| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
Page 6 of 13  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02 If you have these symptoms you should report them to your study doctor who will determine if they are related to the radiation treatments given in the study or to infection. If radiation is the cause, the symptoms are usually temporary and relieved with medication. With medication for pain, you should be able to continue on the protocol. It is not anticipated that these side effects will prevent you from finishing radiotherapy in 4 days. If it becomes necessary to stop your radiation treatments due to other problems (such as a medical illness), you may be taken off this study. At this time, your study doctor will discuss with you other treatment options. MRIs use powerful magnets to make images. Therefore, persons with metal implants, such as surgical clips or pacemakers should not have an MRI. However, there are no known health risks associated with this exposure. People who feel uncomfortable in confined spaces (claustrophobia) may feel uncomfortable in the narrow cylinder. The MRI makes loud banging noises as it takes images. Earplugs can be used to reduce the noises. The MRI can be stopped at any time at your request. Radiology Tests (Mammograms/CT Scans): The radiation associated with these diagnostic radioactive drug and diagnostic x-ray studies will not adversely affect the treatment of your disease. Reproductive risks: Because radiation can affect an unborn baby, you should not become pregnant while on this study. If you have any questions about the reproductive issues or about preventing pregnancy, please discuss them with your study doctor. For more information about risks and side effects, ask your study doctor. If you enroll on this study and experience any of the side effects listed above or others that you are concerned about, you can contact the investigator or another study physician any time of day or night by paging (617) 726-1818.

We will offer you the care needed to treat injuries directly resulting from taking part in this research. We may bill your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but you may also be responsible for some of them. Providing your care does not mean that DF/HCC or the research doctors are at fault, or that there was wrongdoing. There are no plans for DF/HCC to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.  
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| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02 If you think you have been injured as a result of taking part in this research study, tell the person in charge of this research study as soon as possible. The research doctor's name and phone number are listed in this consent form.
Clinical trial: NCT00694577
Section: Procedures
Subsections: What Is Involved In The Study?|Agreement To Video Recording Procedures

You will undergo a thorough evaluation before entering this study. This is to determine if you are eligible for this study. Many of the following evaluations are commonly done to determine diagnosis and/or stage of disease. You may have already had some or all of these evaluations. Evaluations may include: physical examination, medical history, blood tests, a pregnancy test if you are a woman of child-bearing age, and a mammogram. At the discretion of your treating physician, abdominal (stomach), chest and pelvic CT and/or MRI scan and other tests as appropriate for your illness could be ordered. MRIs use powerful magnets to make images. CT scans are X-ray examinations.  
Page 2 of 13  
| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02 You will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before you start study treatment. This planning process is the same as that commonly used to plan conventional radiation therapy treatments. You may be given an intravenous dye ("contrast") to help see the tumor bed; your study doctor will discuss this with you at the time of planning if it is felt to be needed. After this planning session, your radiation oncologist may decide that he or she cannot identify the area of the tumor bed well enough to do partial breast irradiation adequately. In this case, you will not be treated in this study, and conventional radiation treatments will be given. You will also be asked about any drugs you are taking, your ability to carry out normal activities, and how you are currently feeling. If you are pregnant, you will not be able to participate in this study. If these tests indicate you are eligible for this study, you will receive study treatment as an outpatient. Your radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy. (Chemotherapy and radiation therapy will not be given at the same time.)

Your consent to participate should be voluntary and informed. ___ I do ___ I do not consent to video images being recorded during my treatment. Patient Initials: _________ Date: __________________
For MGH Office Use Only: Date Consent Drafted or Revised: 10/20/09  
  
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| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |
Clinical trial: NCT00694577
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

You are being asked to participate in this study because your doctor believes that you should receive radiation therapy for your recently diagnosed breast cancer. Radiation therapy (also known as "radiotherapy") is usually given as a series of daily treatments (Monday through Friday) that last for about 6-7 weeks. The entire breast is treated for most of this period.  
| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02 However, several studies have been performed in which only a portion of the breast near the cancer (called the "tumor bed") is treated. This approach is called "partial breast irradiation". Because only a small portion of the breast is treated, the entire course of radiation treatments on this study can be given in a 1-week period. These previous studies were done by placing catheters (tubes) in the breast in the operating room, then placing radioactive materials in the catheters. This procedure is called an "interstitial implant". So far, these studies have had results very similar to conventional radiation treatments, with a low risk of the cancer reappearing in the breast and low complication rates. It is also hoped that this approach will also reduce the chance of complications arising in the lungs and heart that may happen years after treatment. In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments instead of an interstitial implant. This study treatment will be completed in 4-7 days. No further surgery will be needed.
Clinical trial: NCT00694577
Section: Voluntary Participation
Subsections: Documentation Of Consent

My signature below indicates that I have read this consent form in its entirety, my willingness to participate in this study and my understanding that I can withdraw at any time. Signature of Subject Date or Legally Authorized Representative To be completed by person obtaining consent: The consent discussion was initiated on (date) at (time.)  
  
  
  
For Adult Subjects
The subject is an adult and provided consent to participate.  
  
  
  
  
  
  
  
  
  
Signature of Individual obtaining consent: Printed name of above:
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| DFCI Protocol Number: 03-179   | Approved Date (DFCI IRB Approval):   | 06/13/2019   |
|--------------------------------|--------------------------------------|--------------|
| Date Posted for Use            | 06/14/2019                           |              |  
BIDMC/BWH/DFCI/MGH/Partners Network Affiliates OPRS: 11-02