Clinical trial: NCT02401347
Section: Alternatives
Subsections: Alternatives

Standard chemotherapy if you have triple-negative breast cancer Standard chemotherapy or anti-estrogen therapy if you have estrogen receptor and/or progesterone receptor-positive breast cancer Stanford chemotherapy if you have a non-breast metastatic cancer Enrollment in a different clinical trial, if you meet the eligibility criteria No therapy at this time, with care to help you feel more comfortable
Please talk to your doctor about these and other options available to you for your treatment.
Clinical trial: NCT02401347
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Obtained, Used Or Disclosed?|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?|When Will My Authorization Expire?

The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified. Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction. The purpose of this study is to find out what effect single agent talazoparib will have on your cancer. This study will also look at the side effects associated with this drug. The results will be provided to the drug manufacturer, the Food and Drug Administration and other federal and regulatory agencies as required.  
  
  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study.  
Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.  
What is the purpose of this research study and how will my health information be utilized in the study?  
The purpose of this study is to find out what effect single agent talazoparib will have on your cancer. This study will also look at the side effects associated with this drug.  
Do I have to sign this authorization form?  
You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study, including receiving any research-related treatment. Signing the form is not a condition for receiving any medical care outside the study.  
Participant ID:

If I sign, can I revoke it or withdraw from the research later?  
If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Dr. Melinda Telli, .  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |

Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to, The history and diagnosis of your disease; Specific information about the treatments you received, including previous and future treatment(s);
Information about other medical conditions that may affect your treatment; Medical data including laboratory test results, health status (blood pressure, activity status, smoking status, etc.) tumor measurements, imaging scans (CT or Cat scan, MRI), x-rays, and pathology results; Information on side effects (adverse events) you may experience, and how these were treated; Long-term information about your general health status and the status of your disease; Information that will identify you for the study, such as your date of birth, sex, age, and other medical history You may request a blank copy of the forms that will be used to collect your study data, from the study doctor or his/her research staff to learn what information will be shared.

The following parties are authorized to use and/or disclose your health information in connection with this research study:
The Protocol Director, Dr. Melinda Telli The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary Research Staff

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
The Office for Human Research Protections in the U.S. Department of Health and Human Services The Food and Drug Administration IRB Use Only Approval Date: September 20, 2022 Expiration Date: September 20, 2023  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |  
The drug supplier, Pfizer, Inc.  
Government agencies as authorized or required by law; Other auditors sent for review of research at the site by any of the persons listed above.  
Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.

Your authorization for the use and/or disclosure of your health information will end on December 31, 2025 or when the research project ends, whichever is earlier.  
Will access to my medical record be limited during the study?  
To maintain the integrity of this research study, you may not have access to any health information developed as part of this study until it is completed. At that point, you would have access to such health information if it was used to make a medical or billing decision about you (e.g., if included in your official medical record). ________________________________ ______________  
 Signature of Adult Participant Date
________________________________
Print name of Adult Participant ________________________________ ____________ Signature of Legally Authorized Representative (LAR) Date (e.g., parent, guardian or conservator)
________________________________ ______________________________
Print Name of LAR Authority to Act for Participant
(e.g., parent, guardian or conservator)  
  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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Clinical trial: NCT02401347
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement How Long Will You Be In The Study?

Following the Pre-Study visit you will be required to visit Stanford every 28 days. Each visit will last a few hours depending on the examinations to be performed. The study doctor and research coordinator will inform you of the length of each visit. You will receive study treatment for 12 cycles with talazoparib (first stage of treatment called the Induction Phase). Each cycle is 28 days long. The Induction Phase will be given for up to 12 cycles (or up to about 12 months), unless your disease progresses or side effects of therapy would make it unsafe for you to continue. If after 12 cycles your disease has not progressed and you remain on treatment, you will proceed to the second stage of treatment called the Continuation Phase. You will continue to receive treatment every 28 days. You will continue treatment until your disease progresses or side effects of therapy would make it unsafe for you to continue. Your study doctor will keep track of your medical condition for up to 3 years from the time you enrolled on this study to look at the long-term effects of the treatment.  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |  
Your study doctor may decide to take you off this study if your disease does not improve or if side effects of treatment would make it unsafe to continue. You will be informed of new developments that may become available that might affect your participation in the study.
Clinical trial: NCT02401347
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:  
Follow the instructions of the Protocol Director and study staff.  
Take the study drug as instructed Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.  
Keep the study drug in a safe place, away from children and for your use only.  
Keep your diaries as instructed.  
Complete your questionnaires as instructed. Ask questions as you think of them. Tell the Protocol Director or research staff if you change your mind about staying in the study.
Clinical trial: NCT02401347
Section: Participant's Rights
Subsections: Participant'S Rights|Experimental Subject'S Bill Of Rights

You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director. You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study. If new information is learned that may affect you after the study has been completed, you will be contacted by the study doctor.  
  
  
IRB Use Only Approval Date: September 20, 2022 Expiration Date: September 20, 2023  
| Expiration Date: September 20, 2023   |                                                                                                                                                                                                                                                                                                                                      |
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| Protocol Director:                    | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes |
| Protocol Title:                       |                                                                                                                                                                                                                                                                                                                                      |

As a research participant you have the following rights. These rights include but are not limited to the participant's right to:
be informed of the nature and purpose of the experiment; be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected;  
  
  
| Approval Date: September 20, 2022 Expiration Date: September 20, 2023   |                                                                                                                                                                                                                                                                                                                                      |
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| STANFORD UNIVERSITY                                                     | Research Consent Form                                                                                                                                                                                                                                                                                                                |
| Protocol Director:                                                      | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes |
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be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.  
May we contact you about future studies that may be of interest to you? ____ Yes ____ No Signing your name means you agree to be in this study and that you were given a copy of this signed and dated consent form. _____________________________________ ____________ Signature of Adult Participant Date _____________________________________ Print Name of Adult Participant _____________________________________ ____________ Signature of Legally Authorized Representative (LAR) Date (e.g., parent, guardian or conservator) _____________________________________ Print Name of LAR _____________________________________ LAR's Authority to Act for Participant (e.g., parent, guardian or conservator)  
  
IRB Use Only  
Approval Date: September 20, 2022  
Expiration Date: September 20, 2023  
| Expiration Date: September 20, 2023   |                                                                                                                                                                                                                                                                                                                                      |
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| Protocol Director:                    | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes |
| Protocol Title:                       |                                                                                                                                                                                                                                                                                                                                      |  
____________________________________ _____________ Signature of Person Obtaining Consent Date
_____________________________________
Print Name of Person Obtaining Consent The following witness line is to be signed only if the consent is provided as a summary form and accompanied by a short form foreign language consent.  
_____________________________________ ____________
Signature of Witness Date
Clinical trial: NCT02401347
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Associated With Pregnancy And Nursing:|Possible Risks, Discomforts, And Inconveniences What Are The Risks Of The Medication Or Treatments In The Study?|Other Risks And Discomforts Other Medications

Like any other experimental drug, talazoparib may have unknown and serious risks that could lead to death. If you are pregnant or breast feeding (nursing) a child, you cannot be in this study. Talazoparib was shown to harm the fetus of pregnant rats. Although the risk in humans of harming the fetus, nursing a baby, or losing a pregnancy (miscarriage) while taking talazoparib is unknown, you must use highly effective birth control during the study. If you think you could be pregnant you must tell your study doctor.  
  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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For male patients, if your partner becomes pregnant or for female patients, if you become pregnant, you must immediately notify the study doctor of the pregnancy. The sponsor will ask the study doctor to provide medical information on the pregnancy and the health of the baby.

While you are participating in this study, you should tell your study doctor about all medications that you are currently taking and before starting any new medications (including all herbal and over-the-counter medications). You should also tell your study doctor about any allergies to medications which you currently have or have had in the past. Severe allergic reactions, which may be life threatening, are possible with the medication prescribed in this study. For your safety, you will be monitored throughout the study for any changes that may occur because of the treatment that you receive. There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions. Risks that have been associated with talazoparib are:
Low red blood cell counts (anemia), low platelet counts (thrombocytopenia), and low neutrophil counts (neutropenia)
Low neutrophil count (falls within subgroup of white blood cells) can weaken the immune system and increase the risk of infection, including severe infection or sepsis requiring hospitalization and IV antibiotics Other side effects associated with this drug include: nausea, vomiting, diarrhea, muscle cramps, fatigue, dizziness, hair loss, cough, swelling or irritation of the mucus membranes (mucus membranes form a moist lining for body parts like your mouth, lungs, and digestive tract) and flatulence Talazoparib is considered a cytotoxic agent, subjects should be advised that oral anticancer agents are toxic substances and that (other than the subject) caregivers should always use gloves when handling the capsules. Furthermore, this class of drugs has been associated with a small risk of secondary hematological malignancies, such as acute leukemia. As such, if you decide to enroll in this study, we will pay  
  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |  
very close attention to your laboratory results and will refer you to a hematologist (blood specialist) if your blood counts remain low for more than six weeks. As this is an investigational therapy it may involves risk to the study participant that is currently be unforeseeable. All problems need to be reported to the study doctors or study nurses looking after you either by phone or at the next visit. For more information about risks and side effects, you should feel free to ask your study doctor. If you are concerned about your health between visits due to participating in this trial, please call your study doctor using the telephone numbers provided at the end of this document. In rare instances where a nurse, a doctor, or a laboratory technician sustains an exposure to your blood by needle stick, cut or splash to mucosa or damaged skin, it may be necessary to test your blood for certain viral infections including Hepatitis B, Hepatitis C, and HIV on the blood sample already available. This is to enable that person to receive appropriate counseling, monitoring and treatment, if necessary. In this instance the study doctor will offer you the information relevant to your health and advise you on the next steps. Confidentiality of your data will be respected at all times.

Other drugs may be given to make side effects less serious and less uncomfortable including drugs for nausea, such as ondansetron or prochlorperazine. Other medications may be given to address symptoms of cancer. Please discuss the potential side effects of any new medications with your study doctor. Blood Collection The risks from having blood drawn and or inserting the needle in your vein when giving study drug include fainting, bleeding, bruising at the place on your arm where the blood was drawn or needle inserted, as well as pain, swelling and rarely, infection or nerve damage.
Clinical trial: NCT02401347
Section: Procedures
Subsections: Procedures What Is Involved In This Study? Before You Begin The Study

You will need to have the following exams, tests and procedures done in order to find out if you can safely be in the study. Many of these are part of your regular care and would be done even if you were not to take part in this study. If you have had some of these recently, they may not need to be repeated. You will need to sign this consent form before any study related procedures are performed. Within 4 weeks prior to treatment initiation, the following will be performed:  
Review of your medical history, including any medications you are currently taking. The review will also include an assessment of any history of or risk factors you may have for hepatitis B or hepatitis C.  
Complete physical examination, including an assessment of your heart rate, blood pressure, temperature, height and weight Evaluation of how active you are and your ability to perform every day activities
(performance status)
Radiology or Imaging scans to measure the size and location of the cancer (such as a CT or
"CAT" Scan)
Serum pregnancy test for women of childbearing potential Blood tests including complete blood count and metabolic chemistry panel Hepatitis B and/or Hepatitis C tests may be done if you have any known risk factors. If you have a positive hepatitis B or hepatitis C result, you may be required to take an antiviral medication for 1-2 weeks prior to the first dose of study drug.
The results of these tests will be reviewed by your study doctor to see if you have met all of the requirements for the study. DURING THE INDUCTION PHASE OF THE STUDY If the exams, tests and procedures show that you can be in the study and you choose to take part, then you will need the following exams, tests and procedures during the study: Day 1 of Each Cycle- At least once every 28 days, the following will be performed:
Physical examination including heart rate, blood pressure, temperature, and weight  
  
  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |  
Review of any medications you are currently taking  
Evaluation of how active you are and your ability to perform every day activities
(performance status)
Blood tests including complete blood count and liver and kidney function tests. Additional blood may be required to perform tests for hepatitis B and/or hepatitis C if you had a positive result prior to the start of the study. Please note: You will have a complete blood count measured once every two weeks for the first two cycles.  
Check to see how you are taking the study medication at home. You will be asked to complete a Patient Pill Diary. Please bring your study medication and Patient Pill Diary to each visit.  
Monitoring of side effects - you should tell your study doctor if you have new problems at any time when they occur. Your study doctor or nurse will also ask you about new problems before the start of a new study cycle. You should also tell your study doctor if you are taking any other medications.
Once every 8 weeks (every 2 treatment cycles) the following will be performed:  
Radiology or Imaging scans to measure the size and location of the cancer (such as a CT or
"CAT" Scan). You may have additional radiology tests during the study if your study doctor feels it is necessary.
DURING THE CONTINUATION PHASE (AFTER COMPLETION OF 12 CYCLES OF THERAPY IN THE INDUCTION PHASE) You will continue to receive single-agent talazoparib. At each clinic visit, we will evaluate the following:
Complete blood count and kidney and liver function tests.  
You will continue to complete a Patient Pill Diary. Please bring your study medication and Patient Pill Diary to each visit.  
Monitoring of any unresolved side effects - you should tell your study doctor if you have new problems at any time when they occur. Your study doctor or nurse will also ask you about any ongoing problems after you have stopped taking the study medication. You should also tell your study doctor if you are taking any other medications.
Once every 12 weeks (every 3 treatment cycles) the following will be performed:  
Radiology or Imaging scans to measure the size and location of the cancer (such as a CT or
"CAT" Scan). You may have additional radiology tests during the study if your study doctor feels it is necessary.
You can discuss the details of the study calendar with your study doctor or the study staff. AFTER END OF FIRST STAGE OR END OF ALL TREATMENT  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |  
When you go off the study you will be asked to return for a follow-up exam within 30 days after receiving your last dose of talazoparib. The following tests and procedures will be done at the off-study visit:
Physical examination including heart rate, blood pressure, temperature, and weight  
Review of any medications you are currently taking Evaluation of how active you are and your ability to perform every day activities
(performance status)
Blood tests including complete blood count and kidney and liver function tests.  
Final check to see how you took the study medication at home. Please bring your study medication and completed Patient Pill Diary.  
Monitoring of side effects - you should tell your study doctor if you have new problems at any time when they occur. Your study doctor or nurse will also ask you about any ongoing problems after you have stopped talking the study medication. You should also tell your study doctor if you are taking any other medications.  
Radiology or Imaging scans to measure the size and location of the cancer (such as a CT or
"CAT" Scan), if due.
Once you have come off study, you will be followed for 3 years from the date you were randomized to the study. Your doctor will ask you about problems that were ongoing at the time you came off the study. The following tests and procedures may be done approximately every 3 months:  
Complete blood count - only if there are any ongoing side effects.  
Radiology or Imaging scans to measure the size and location of the cancer (such as a CT or
"CAT" Scan), if your cancer had not previously progressed (gotten worse).
Clinical trial: NCT02401347
Section: Purpose of Research
Subsections: Purpose Of Research

You are invited to participate in this clinical trial (a type of research study) because you have HER2 negative breast cancer or a non-breast metastatic solid tumor that has spread outside of the breast or other part of body (metastasized) and which may be sensitive to a class of drugs called PARP inhibitors. This study is a single-arm clinical trial, which means all participants will receive the study drug. The information in this form is part of a process called informed consent, which will allow you to make a decision about whether you want to volunteer for this clinical trial. Your study doctor will also explain the clinical trial to you. Clinical trials include only those people who choose to take part. Please take your time to make your decision and discuss it with your friends and family. Once all of your questions have been answered, if you still wish to take part, you will be asked to sign this form. Your study doctor and/or a member of the study team will also sign the form. You will receive a copy of the form to keep. If you have any questions at any time during the research study, you should feel free to ask them. You will receive answers to your questions in a way that you will be able to understand. You are not giving up any of your legal rights by volunteering for this research study or signing this consent form. This is an investigator-initiated led by Dr. Melinda Telli. This research study contains two patient cohorts. Each cohort is looking for a total of 20 patients. Cohort A consists of patients with sporadic (i.e. lacking an inherited form of the BRCA1 or BRCA2 gene mutation), advanced triple-negative (estrogen receptor-/progesterone receptornegative, and HER2-negative) breast cancer with faulty DNA repair mechanisms based on a new tumor tissue assay produced by Myriad Genetics. Cohort B consists of patients with HER2negative breast cancer or non-breast metastatic solid tumors with either evidence of a hereditary breast cancer syndrome, excluding BRCA1 or BRCA2, or with evidence of genetic changes in the tumor tissue, making the tumor sensitive to the study agent. Enrollment will only occur at the Stanford Women's Cancer Center. If you decide to terminate your participation in this study at any time, you should notify Dr. Melinda Telli at .  
  
| Protocol Director:   | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes   |
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| Protocol Title:      |                                                                                                                                                                                                                                                                                                                                        |  
WHY IS THIS STUDY BEING DONE?  
Studies have documented tumor shrinkage when using this class of study agents called PARP
inhibitors in advanced breast cancer patients who carry an inherited BRCA1 or BRCA2 mutation.  
It has been suggested that PARP inhibitors may also have a role in the treatment of triplenegative breast cancer patients, who do not have an inherited risk, but whose tumors have similar DNA repair defects.  
Likewise this study agent may have a role in the treatment of breast cancer patients with different inherited mutations affecting the same DNA repair pathway, or similar types of mutations arising in the tumor tissue itself.
The **purpose of this study** is to evaluate if treatment with the study drug, talazoparib, causes tumor shrinkage in breast cancer and non-breast cancer patients whose tumor cell's have impaired ability to repair DNA.
Clinical trial: NCT02401347
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.
Clinical trial: NCT02401347
Section: Withdrawal from Study
Subsections: Withdrawal From Study What Will Happen If I Do Not Wish To Participate Or Decide Not To Continue In The Study?

Taking part in this study is your choice (voluntary). You may choose not to take part or may leave the study at any time. Leaving the study, or choosing not to take part, will not affect further treatment options or your relationship with your doctor. If you do not wish to participate in this trial, your doctor will discuss your other treatment options with you. You can change your mind at any time and withdraw your permission to allow your personal health information to be used in the research. Beginning on the date you withdraw your permission, no new personal health information will be used for research. However, researchers may continue to use the health information that was provided before you withdrew your permission. If you decide to withdraw your consent to participate in this study, you should notify Dr. Telli at
.  
If you withdraw from the study, or the study medication is stopped for any reason, we will ask you to return all study-related supplies, including unused study drug.  
  
| Expiration Date: September 20, 2023   |                                                                                                                                                                                                                                                                                                                                      |
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| Protocol Director:                    | Melinda Telli, M.D. A Phase II clinical trial of the PARP inhibitor talazoparib in BRCA1 and BRCA2 wild-type  patients with advanced triple-negative breast cancer and homologous recombination deficiency  or advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous  recombination pathway genes |
| Protocol Title:                       |                                                                                                                                                                                                                                                                                                                                      |  
The Protocol Director may also withdraw you from the study and the study medication may be stopped, without your consent for one or more of the following reasons:
Failure to follow the instructions of the Protocol Director and study staff. The Protocol Director decides that continuing your participation could be harmful to you.  
Pregnancy You need treatment not allowed in the study.  
The study is cancelled. Other administrative reasons.  
Unanticipated circumstances.