The purpose of this study is to determine which routine course of treatment, docetaxel or paclitaxel, will result in less servere nerve damage known as peripheral neuropathy for African-American women with breast cancer.
This study will assess the safety and toxicity of oral Curcuma longa extract (Curcumin) in patients with breast cancer.
The overall goal of this study is to see if taking BCM-95 (curcumin) will change the make up of the tumors of patients who have breast cancer. BCM-95 is a supplement made from the curcumin plant, which helps to reduce inflammation in the body. BCM-95 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 determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.
The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.
The purpose of the study is to test the safety and effectiveness of the study drug, pembrolizumab (MK-3475) with certain types of chemotherapy and endocrine therapy, as well as, to see how well the subject's body handles the study drug.
If subject's meet the criteria, they will be assigned to 1 of 2 groups by chance, similar to flipping a coin, in order to decide which study treatment they will receive. Group A will receive the study drug, pembrolizumab, with certain types of chemotherapy and endocrine therapy. Group B will receive placebo, with certain types of chemotherapy and endocrine therapy. Pembrolizumab or placebo will be given by vein about once every 3 weeks.
This is a long-term study, if subject's agree to participate, they will be in the study for approximately 12 years.
This study is for breast cancer patients who are making decisions about breast cancer surgery. This study is being done to learn about how patients and their surgeons make decisions about breast cancer surgery.
Outcomes following a breast cancer diagnosis are different by race and ethnicity with African American women having poorer survival compared to Caucasian women. Research has shown that differences in personal health factors can contribute to breast cancer outcomes and explain racial differences. This study will examine how personal-level factors relating to biological, psychological, and physiological issues play a role in outcomes among African American breast cancer survivors.
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 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.
This study is for women or men with hormone responsive breast cancer that has already been removed by surgery and have completed any required chemotherapy or radiation. The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study subjects will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
It is expected that subjects will be enrolled in this study for approximately 54 weeks or until side effects become too great, or until cancer returns. After subjects are finished with study treatment, they will return to the clinic every six months for the first 2 years and then yearly for the next 10 years.
This study is being done for the following reasons:
•This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
•The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
•In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.