This trial is evaluating whether Durvalumab will improve 1 primary outcome and 4 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 18 weeks.
This trial requires 39 total participants across 2 different treatment groups
This trial involves 2 different treatments. Durvalumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Treatment of men with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is much like treatment of women. Common treatment options for breast cancers in men include hormone medication and surgery. Men can also receive chemotherapy, radiation therapy, or a combination of these. Common treatment options for breast cancers in men include axillary surgery and hormone medication. However, in certain cases, surgery may be necessary to remove all cancer cells from the lymphatic system such as in stage III disease. Treatment options for other cancers, including non breast-related cancer types are similar for men and women.
The incidence of cure for breast cancer has not declined in the last 30 years. It has, however, been demonstrated that this has not led to a cure in the last 10 years. With very good care, a cure rate of over 90 percent can be achieved.
Many women have [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s and many experience discomfort from their first diagnosis. The breast looks like a lumpy pain in the breast or a bump. Some cancer experts even recommend against mammograms, because they think that the chances of a cancer is low. What is breast cancer?
The number of new [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cases reported in 1999 was 8.4% of cases for women aged 50 to 69. At age 70 to 74, the rate was 22.4%. Breast cancer accounts for 16% of deaths in US women ≥ 50. There was a 28% increase in breast cancer mortality from 1987 to 1995. Cancer and Death Statistics, 2000, 2001, 2001-2; U.S. Cancer Registry, 2000; American Cancer Society. American women born in 1900 (incomplete link) U.S. Cancer Information for the Public, 1999-2000, 2001. U.S. Cancer Registry. 2002-. Cancer and Death Statistics, 2002, 2005-6; National Center for Health Statistics.
The most commonly reported signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in women are the following: a) palpable lump in the breast, and b) pain/swelling in one or both breasts, both of which are the result of local invasion, and c) enlargement of the breast in women who are still menstruating.
Although cancer does have multiple causes, it is usually caused by inheritable genetic risk factors, such as a family history of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) or a mutation in the BRCA1 or BRCA2 gene. Women born to a first degree relative with breast cancer have a 20-50% increased risk of breast cancer themselves, compared with women without a family history. Men-to-women transmission of the BRCA1 and BRCA2 genes is even higher. These women should discuss their risks of breast cancer and should consider early screening with mammography. Men-to-women transmission of other benign or malignant breast tumors has not been studied thoroughly.
Durvalumab induced common side effects in patients with advanced (or metastatic) breast cancer. These side effects may result in patient non-adherence despite persistence over time. However, most patients were either compliant with treatment or the side effects were manageable, but many were impacting patients' functionality.
In this review, a summary of the key developments in the therapeutic use of Durvalumab are described. It has been shown to be active and safe in patients receiving it as a monotherapy for HR+/HER2- advanced breast cancer. It may be that this and other anti-PD-1 or anti-PD-L1 inhibitors will provide a new approach to patients with HR+ advanced breast cancer who relapse after standard of care chemotherapy.
The combination of durvalumab and the following treatments were found to be the most frequently used combinations: pemetrexed and paclitaxel (3%), capecitabine and pemetrexed (3%), docetaxel, capecitabine and pemetrexed (3%), and docetaxel, capecitabine, and bevacizumab (1%).
Durvalumab demonstrated a longer ORR, DFS, and OS compared with placebo and was better than trastuzumab in HR+/HER2+ metastatic breast cancer. Compared with trastuzumab, its benefit was limited.
While the survival rate for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is not the lowest when compared to all other cancers, it is lower when the tumor is very small.
A cause of estrogen receptor positive breast cancer is unknown. However, an association with obesity and insulin, particularly type II diabetes, raises the possibility of a link between the two. A relationship with obesity, which is increasing in Western society, and the rise in metabolic syndrome and related hyperinsulinaemia is particularly important as the latter is the cause of two-thirds of insulin-treated type II diabetes worldwide.