UC Davis Health Clinical Studies

A Study of Experimental Elacestrant vs. Standard of Care for ER+/HER2- Advanced Breast Cancer

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You are being asked to take part in this research study because you have advanced breast cancer that is either: - estrogen receptor positive (ER+) or - human epidermal growth factor negative (HER2-) Researchers want to find out if an experimental drug called elacestrant, can help people with your type of advanced breast cancer. Elacestrant is also known as RAD1901. It is an experimental drug that impacts the estrogen receptor. It is under investigation for the treatment of ER+, HER2- advanced breast cancer. An “experimental drug” is a drug that is being tested and is not approved for sale by the FDA. Researchers want to test elacestrant in subjects with advanced breast cancer. They hope to learn: - if it can prolong time to worsening (progression) of the breast cancer, - how it affects cancer cells and - about any unwanted health effects, also called “side effects”, it may cause.

Drug study, Phase 3
Any, age 18 years or older

A Study of Experimental Tucatinib vs. Placebo Combined With Ado-trastuzumab Emtansine (T-DM1) for HER2+ Breast Cancer

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We’re asking you to take part in a clinical trial (study) because you have HER2 positive breast cancer that has started to spread or has already spread through your body. “HER2 positive” means that your cancer cells make a protein called HER2. This clinical trial uses an experimental drug. This means the Food and Drug Administration (FDA) hasn’t approved it for sale in the United States. This drug is called tucatinib. This trial also uses another drug called ado-trastuzumab emtansine (T-DM1). The brand name for T-DM1 is KADCYLA®. T-DM1 has already been approved by the FDA for treatment of your type of breast cancer. Your doctor might choose to talk with you about this treatment even if you’re not in this clinical trial. We are studying tucatinib plus T-DM1 to find out what the side effects are and if it works for treating HER2 positive breast cancer. A side effect is anything the drug does to your body besides treating your disease. We don’t yet know if tucatinib plus T-DM1 is better or worse than other treatments. Learning about the side effects of tucatinib plus T-DM1 and how it works will help us understand if tucatinib plus T-DM1 is better or worse than other treatments. We want to find out how effective tucatinib plus T-DM1 is compared to treatment with only T-DM1. To do this, we will compare 2 groups in this study. One group will get tucatinib plus T-DM1 and the other group will get a placebo plus TDM1. A placebo is a pill that doesn’t have any drug or medicine in it. We will choose your group randomly, like tossing a coin. This means that you might get tucatinib plus T-DM1 or you might get placebo plus T-DM1. We won’t know which group you’re in until the end of the clinical trial. Your doctor and the study staff won’t know which group you’re in either. Clinical trials include only people who choose to be in them. Please take as much time as you need to make this choice. You can talk with your friends and family about your options. You can also talk with other doctors and nurses you know. If you have any questions, ask your study doctor before making your choice. This form tells you about the risks and possible benefits of this clinical trial. It explains what will happen if you take part. Your study doctor will also explain the clinical trial to you. After you read this document and have your questions answered, we will ask you to decide if you want to be part of this clinical trial. This process is called informed consent. You have other options to consider for your breast cancer. Discuss these options with your doctor so that you know the risks and benefits of all your choices before you decide. When you understand the study, including the risks and benefits, you must sign this form if you want to take part in the study. We will give you a copy of the signed form to keep

Drug study, Phase 3
Any, age 18 years or older

Experimental Atezolizumab Before and/or With Chemoradiotherapy for Locally Advanced Cervical Cancer

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The purpose of this study is to see if adding the experimental drug, atezolizumab, helps your immune cells to better fight your cancer. Adding atezolizumab to the usual treatment could lower the chance of your tumor growing or spreading. It could also cause side effects. The study drug is approved by the FDA, but not for cervical cancer. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if atezolizumab enhances the ability of your immune cells to fight the cervical cancer. An extra tube of blood will be drawn and some of the tissue collected during your biopsy will be used to study this ability of your immune cells. The study doctors do not know if using the study drug will be better, the same, or worse than not using the study drug. If it is better, this test should help doctors determine which patients will respond best to this type of treatment for cervical cancer.

Drug study, Phase 1
Female, age 18 years or older

A Study of the Experimental Combination of Radiation Therapy and Olaparib For Inflammatory Breast Cancer

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The purpose of this study is to test adding the study drug (olaparib) to standard treatment. The addition of olaparib to standard treatment may or may not prevent your cancer from returning. This study will help study doctors learn if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients. The drug olaparib is approved by the FDA for use in other cancers. Olaparib is not approved for inflammatory breast cancer and is considered experimental in this study.

Drug study, Phase 2
Any, age 18 years or older

Experimental Study of a New Drug Combination - Copanlisib and Fulvestrant - in Postmenopausal Women With Advanced Breast Cancer

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The purpose of this study is to compare any good and bad effects of using a specific drug, copanlisib. It will be given along with standard therapy with fulvestrant for advanced breast cancer. The addition of copanlisib to the usual therapy of fulvestrant alone could shrink your cancer/prevent it from returning. It could also cause side effects. The genetic make up of your breast cancer will be important to know before you start treatment in the trial. If you have a protein called PI3K or PTEN, copanlisib may work better when given with fulvestrant to block cancer cell growth. PI3K and PTEN are often altered (or mutated) in cancer cells. If you do not have PI3K or PTEN alterations in your tumor you may still benefit from this therapy. Researchers hope to learn if tumor genetic information is important in predicting if your cancer will respond to fulvestrant and copanlisib. This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the addition of copanlisib should shrink breast tumors in about 1 out of every 3 patients treated on this study. Copanlisib is already FDA approved for use in follicular lymphoma. It is usually not used for the treatment of breast cancer and is considered experimental in this study.

Drug study, Phase [/1/,/ /2/]
Female, age 18 years or older

A Study of Experimental Accelerated vs Standard Chemotherapy for Germ Cell Tumors (formed from reproductive cells)

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Standard treatment for advanced germ cell tumors includes three chemotherapy drugs. This is called BEP (Bleomycin, Etoposide, and cisPlatin). BEP is given with a drug called pegfilgrastim or filgrastim. This makes white blood cells grow. These drugs are given over the course of 3 weeks. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen. It will use the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3 week-cycle, patients would receive their treatment in a 2 week-cycle. The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don’t yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question.

Drug study, Phase 3
Any, age 11 to 45 years old

A Study of an Experimental Combination Therapy of Radiation With or Without Cisplatin for Recurrent Endometrial Cancer

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The purpose of this research is to compare two different treatments for endometrial cancer: - radiation therapy combined with weekly treatment with the chemotherapy drug cisplatin and - radiation therapy alone. You are invited to be in this study because you have endometrial cancer that has come back (recurred) after surgery and chemotherapy. Your cancer does not appear to have spread beyond your pelvis.

Radiation study, Phase 2
Female, age -1 years or older

A Study of the Effect of an Oral Vaccine on the Digestive System

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The purpose of this study is to: 1. Determine whether ingesting the standard, 4-doses of a live, weakened typhoid fever vaccine will cause a temporary leaky gut and inflammation. Leaky gut is a condition when the gut lining becomes more permeable, or “leaky”, for substances in the gut to pass through to the tissues beneath it. 2. Compare the gut leakiness caused by this vaccine to the gut leakiness caused by a short-term ingestion of aspirin. 3. Examine whether the size of the body’s natural immune response to this vaccine is associated with gut leakiness and inflammation of similar size.

Biological study, Phase 1
Female, age 18 to 49 years old
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