The primary objective of the proposed research is to develop and validate prediction biomarkers for Radiotherapy-induced acute and chronic skin reactions and quality of life in five racial/ethnic groups of breast cancer patients, Whites, Black/African Americans (AA), Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and American Indians/Alaskan Native
This study is for subjects who have been diagnosed with HER2+metastatic breast cancer. This is an observational study and will follow the regular medical care and treatments given to subjects who have been diagnosed with HER2+ metastatic breast cancer. Subjects will not be asked to take an experimental drug or participate in any experimental procedures. The main purpose of this study is to collect information on how subjects who have metastatic breast cancer are treated, and how they respond to the various treatments for this disease. Because this is an observational study, your doctor will determine the best treatment for you.
After enrollment, each subject's doctor will provide information about the history of their metastatic breast cancer, results of tests done for their cancer, and past treatments they have received. Four times per year (every 3 months), each subject's doctor will provide Genentech with information about their ongoing breast cancer treatment, results of tests performed, response(s) to treatment, and any complications experienced. Subjects' doctors will continue to provide this information four times per year for 5 to 8 years from the time subjects are enrolled in this study.
To understand how subjects are feeling, they will be asked to complete several questionnaires at baseline and periodically throughout study participation, during site visits and remotely, to assess overall health status, activities of daily living, and if they have had any other health issues. Subjects will be enrolled in this study for 8 years. Also, depending on when subjects are enrolled during the 36 month enrollment period, subjects will be followed for 5 to 8 years.
This study is being done because many women who are on oral Aromatase Inhibitor therapy for a long period of time don’t take it regularly. The purpose of this study is to find out the reasons why women don’t take it regularly and also to see if text messaging will help women remember to take their Aromatase Inhibitor medication and stay on the treatment.
This study is for subjects that have cancer that has spread or that cannot be cured by surgery, drugs, or any other known treatments. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. CC-122 belongs to a new class of drugs called “PPMs.” These drugs affect how the immune system works, slow the growth of tumor cells and block blood vessel growth in tumors. Approximately 100 people will take part in this study. The goal of this study is to test the highest, and/or the near-highest tolerated dose level. It may be necessary to test more than one dose level. This study will take place in the United States and in countries in Europe. This study will take about 18 to 24 months to complete. This study is only open to certain types of cancer including: (1) locally advanced (including inflammatory) breast cancer (LABC), (2) hepatocellular carcinoma (HCC), (3) certain types of brain tumor called glioblastoma multiforme (GBM), (4) multiple myeloma (MM), and (5) diffuse large B-cell lymphoma (DLBCL).
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 for adult females who have been newly diagnosed with breast cancer that includes surgery as part of standard cancer treatment. This is a research study combining Vitamin D (an over the counter medication) with the standard of care (or the established and approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer. Screening tests will be done to determine if subjects are eligible to participate in this study. If subjects are eligible and they agree to participate, they will be assigned to one of two groups which will receive different amounts of vitamin D. Subjects will be asked to keep a medication diary. Subjects may remain on treatment for approximately 56 days.
This study is for subjects with HER2-positive breast cancer that has spread to the brain. Lapatinib is an FDA approved drug for treating those with progressive HER2-positive metastatic breast cancer. However, the combination of brain radiation and lapatinib for the treatment of brain metastases is experimental and thus the outcomes are unknown. The combination is being tested because lapatinib was found to improve the effectiveness of radiation therapy in the laboratory. An early study in subjects showed that brain radiation and lapatinib can be combined safely.
The purpose of this study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT) on patients and their cancer. The study will try to discover whether WBRT or lapatinib plus WBRT is better at safely improving tumor control. In this study, subjects will receive either lapatinib plus WBRT or WBRT alone. Subjects are expected to receive treatment for 3 weeks and will then follow up with the doctor every 12 weeks for the rest of their lives.
The purpose of this study is to compare radiation therapy given with a higher daily dose over 3 weeks with a boost given each day of radiation therapy compared with standard whole breast radiation followed by a boost given on separate days which extends over 6 to 6 ½ weeks. It is not expected that there would be a difference in survival by changing the number of daily treatments and shortening the length of time needed for treatment. However, shortening treatment length could be more convenient and save time and money. It is not known, but it is hoped, that the higher daily dose of radiation to the breast has the same chance or better of preventing the breast cancer returning compared to standard daily doses of radiation.
In this study, subjects will get either a standard daily dose of radiation therapy to the whole breast followed by additional radiation to only the area of the surgical cavity (boost) using the same standard daily dose of radiation OR a higher daily dose to the whole breast and to the boost on the same days but in a shorter overall number of daily treatments.
The goal of this study is to help researchers learn better ways to coordinate patients’ care between physician specialists, nurses, social workers and other care providers—called multidisciplinary care (MDC). The assumed benefits of MDC include improved satisfaction for stakeholders such as better informed and satisfied patients and physicians, streamlined care coordination and decision-making across multiple physician specialists, and a greater ability to evaluate patients for enrollment into clinical trials.
Subjects will be asked to allow researchers to look at their medical records and record some information including race/ethnicity, age, clinical diagnosis, tumor grade, and other health conditions, such as high blood pressure and treatment history. Subjects may also be asked to complete a survey about their cancer care.