This trial is evaluating whether CX-2009 will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 30 months.
This trial requires 200 total participants across 3 different treatment groups
This trial involves 3 different treatments. CX-2009 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
There is no evidence that one form of cancer treatment is more effective than any other in removing a cancer from the brain or in prolonging the lifespan of an individual affected by cancer. This paper, therefore, makes no claim of efficacy of any form of treatment to achieve complete remission of breast cancer except that it is an unsupported belief. Therefore, there may be no 'cure'.
The current incidence of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is increasing. More than one in two young women will be diagnosed with breast cancer. Breast cancer may become the most common form of cancer among women under age 45 by 2034.
Most women with breast cancers, particularly ERpositive tumors, are likely to benefit from surgery followed by adjuvant therapy, chemotherapy, and/or anti-estrogen medications for approximately 5 years after diagnosis. Women with large tumors (> 2 cm) may require lumpectomy, axillary lymphadenectomy, radiotherapy, or all three (combined) therapies. Women with BCS (< 1 cm with histologic positive margins for invasive tumors) may do well with simple surgery or radiation alone, but need to have periodic follow-up for ~10 years.
Breast cancer is a disease which can affect both women and men. It causes lump and pain in the breast, a lump which may become bigger, may feel and look like an infected lump. It can spread to surrounding tissues and spread outside the breast. Women who are diagnosed by their doctor can be treated to slow or stop the worsening of the cancer. If breast cancer is diagnosed by a screening mammogram it is easier for it to be diagnosed and treated earlier. After breast cancer is diagnosed by a screening mammogram the chance that it will occur after the woman is diagnosed is less than 1%.
There is often no apparent indication of breast cancer. Screening of women from the age of 35 to 75 years has been shown to reduce deaths from breast cancer, and it shows good value financially for the UK National Health Service.
The authors conclude that there is not only a need for clinical trials using more novel combinations of drugs and delivery systems, but also for better methods to interpret and compare the results of those that have been completed.
For people with breast cancer, there is a good risk between survival and death, although survival rates vary for people with breast cancer. There are certain factors which may affect survival rate. These include age, race, grade, tumor size, stage, and whether or not the person has had prior chemotherapy. \n
There is no clear evidence that the method of biopsy has any impact on outcomes for T1 and T2 breast cancers. There is evidence to support the role of adjuvant systemic therapy to axillary node-dense breast cancers in the absence of positive margins.
The first important step in the treatment of breast cancer is establishing and maintaining the standard that all newly diagnosed patients receive a lumpectomy, radiation, and, if appropriate, anti-estrogen therapy. The second step is maintaining adjuvant treatment after surgery. There have not been any adjuvant drugs approved by the Food and Drug Administration (FDA) that can reliably prolong overall survival, so there is an urgent need to identify new therapeutic approaches. The use of targeted therapies represents an opportunity for improving outcomes. Oncologists could use more research to develop therapeutic approaches that can reliably increase overall survival, and also identify drugs that can be better tolerated by patients to achieve an improved quality of life.
Based on this study, women at 40 and younger are much more likely to develop breast cancer than women of 60 or older and the vast majority of them have a 1-in-3 chance to develop breast cancer. At any given age, women appear to develop breast cancer at around the same rates. The odds of developing breast cancer before ages 20 and 40 are similar (around 1 in 2), although the odds of breast cancer appear higher at age 40 (3 in 4 women). The odds of developing breast cancer at age 50 and later are lower than at age 40 and younger (1 in 4). The risk of developing breast cancer doubles at age 50.
The side effects of Cx-2009 were minimal in the majority of patients. The most troublesome side effects included headache, vomiting, nausea, hyperbilirubinaemia, and rash. Although uncommon, serious or life-threatening hypersensitivity reactions were reported more frequently in patients on the higher-intensity Cx-2009 regimen.