You are being invited to take part in this research study, because you have a certain type of breast cancer called HER2 (Human Epidermal Growth Factor Receptor 2)-low expressing breast cancer that has spread and/or cannot be completely removed by surgery. The main purpose of this study is to gather information about an experimental drug, DS-8201 a, that may help to treat your disease, as well as, compare it to other standard or "comparator" treatments.
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 is for patients with HER2-positive breast cancer that has metastasized. The study is being done to see if the patient's breast cancer can be stabilized and the time that the patient lives with this breast cancer can be lengthened by adding a new drug to the usual combination of drugs.
This study is for patients who are 70 years old or over and have been recently diagnosed with estrogen receptor positive, HER2 negative metastatic breast cancer. The purpose of this study is to find out the side effects that the standard, FDA-approved combination treatment of letrozole or fulvestrant and palbociclib has on patients 70 years old and over.
This study is for patients with breast cancer who have enrolled or are planning to enroll to the Alliance study A011502, "Aspirin for Breast Cancer Study" (or ABC study).
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.