It is well known that treatment with an aromatase inhibitor (AI) can cause side effects that result in symptoms such as joint pain and stiffness, which can interfere with activities of daily living. In some patients, the treatment has to be stopped because of these symptoms.
The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone/placebo is a gel that will be applied to the body in non-fat pad areas. In this study, patients will receive either the testosterone or placebo. They will not receive both.
The study agent, testosterone, used in this study is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA has allowed the use of this agent for this research study.
The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. This reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.
The overall goal of this study is to see if taking BosPure (boswellia serrata) will change the make up of the tumors of patients who have breast and colon cancer. BosPure is a supplement made from the boswellia serrata plant, which helps to reduce inflammation in the body. BosPure is not approved by the United State Food and Drug Administration (FDA) for the treatment of your disease.
The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer. The term ?AGE? (advanced glycation endpoints) refers to sugar-derived metabolites that are linked to lifestyle choices and can contribute to cancer.
Some drugs used to treat cancer raise a patient?s risk of febrile neutropenia. Febrile neutropenia is a condition that involves a fever and a low number of neutrophils (a type of white blood cell) in the blood. Having a low number of neutrophils puts a patient at risk of infection. Colony-stimulating factors (CSFs) are medications sometimes given to patients getting cancer treatment to prevent or treat febrile neutropenia. CSFs are given as an injection under the skin or into a vein.
Current guidelines say that doctors should give CSF during cancer treatment based on how likely it is that the drugs will raise the risk of febrile neutropenia. Research shows that many doctors do not follow these guidelines. This may be harming patients. Underuse of CSFs can raise a patient's risk for febrile neutropenia. Overuse or unneeded use of CSFs can lead to side effects, like bone and muscle pain, but give no benefit and can be costly to the patient.
In some clinics there is an automated system that helps doctors decide when to use CSFs. The system prescribes CSFs when there is a high risk that the drugs will cause febrile neutropenia. It does not prescribe CSFs when there is a low risk that the drugs will cause febrile neutropenia. The research study team wants to find out if this type of system can help doctors use CSF when it is needed and not use it when it is not needed. The study team also wants to learn about the benefits and risks of using CSF with cancer treatment drugs that have a moderate (not high and not low) risk of febrile neutropenia.
The purpose of this study is to find out if the drug ribociclib (LEE011), when taken with standard treatment, everolimus (Afinitor®) and exemestane (Aromasin®), is safe and beneficial in men and postmenopausal women who have advanced breast cancer that has recently become resistant to anti-estrogen therapy (meaning that your tumor progressed while on or being recently treated with anti-estrogen treatment). Participants in this study will remain on this study until his/her disease gets worse, or he/she no longer wish to participate.
The purpose of this study is to test study treatments that combine an investigational drug (ONT-380) with two approved drugs (capecitabine and trastuzumab) in subjects with advanced breast cancer to find out what effects, good or bad, it may have on you and your disease.
The purpose of this project is to understand how characteristics of mammography facilities, mammography providers, and individual patients influence Black women?s experiences receiving an initial abnormal mammography is determined to be non-cancerous (false positive result). Observations, recordings, surveys and interviews will be used to collect information regarding the various influences on Black women?s experience with a false positive mammography result and their intentions to complete future screening mammograms.
This study is for females, ages 25-55, who have tested positive for atypia (early cell changes that are thought to be a marker of breast cancer risk) in the breast, and are considered high risk for the development of breast cancer in the future.
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (marker of breast cancer risk) in women at increased risk for breast cancer. This study will test for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study sponsor would like to compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. In this study, patients will get either metformin or a placebo (an inactive product) for the first twelve months. After the first twelve months, women who received placebo during the first twelve months can choose to receive metformin for the second year.
Note: The standard drug used for the ?breast cancer prevention? is tamoxifen. If you are eligible to take tamoxifen, you must be offered tamoxifen prevention as part of your clinical care and you must have refused tamoxifen treatment to be on this study. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen.
While on this research study patients will have the Random Periareolar Fine Needle Aspiration (RPFNA) of their breasts to test for atypia (marker of breast cancer risk), before the study starts, and also at 12 and 24 months (24 month optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) after the study starts. If the pathologist does not identify atypia in the samples you will not be able to participate. You will also provide blood during this study to determine if changes in your blood are related to changes in your breasts. You will need to provide a little less than 4 tablespoons of blood for this research study.
Study participation will last for 48 months (2 years).
This study is for patients who have been diagnosed with metastatic triple-negative breast cancer. The investigational drugs in this study are cobimentinib in combination with paclitaxel. The purpose of this study is to estimate the clinical benefit of cobimetinib and paclitaxel relative to placebo and paclitaxel, as
measured by investigator-assessed progression-free survival (PFS). The study will be conducted in two stages. The first stage is a safety run-in stage, which is designed as an early test of the combination of cobimetinib and paclitaxel. In this stage the combination will be given to approximately 12 subjects to evaluate any side effects of the combination. The second stage is the expansion stage where approximately 100 subjects will be given either cobimetinib paclitaxel or placebo paclitaxel (placebo is an inactive substance that looks like cobimetinib). Participants can expect to be in this study for approximately 12 months.