This trial is evaluating whether Olaparib will improve 1 primary outcome, 7 secondary outcomes, and 4 other outcomes in patients with BRCA 1 Gene Mutation. Measurement will happen over the course of Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months..
This trial requires 302 total participants across 2 different treatment groups
This trial involves 2 different treatments. Olaparib 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 3 and have had some early promising results.
"The most common treatment for breast cancer is lumpectomy; however, mastectomy is the most common removal procedure for the disease. In addition, chemotherapy is often used as an adjuvant treatment for both lumpectomy and mastectomy procedures." - Anonymous Online Contributor
"A total of 1,814,300 men and 1,531,700 women in the US were diagnosed with breast cancer during the year 2010. Approximately 0.83 percent men and 0.76 percent women were diagnosed with breast cancer each month in the year 2010. The average age when breast cancer was diagnosed in men and women was 54 years. Breast cancer is a disease that can affect males and females equally. In 2000 approximately two-thirds of US men and one-third of US women had screening mammograms within the 12 months following breast cancer diagnosis. Screening reduces the rate that new cases of breast cancer occur by 40%." - Anonymous Online Contributor
"Breast cancer susceptibility is conferred mostly on women's sex. Some genes may be involved in determining risk, but several other factors such as diet, body weight, hormones, and infectious agents may also affect breast cancer risk.\n" - Anonymous Online Contributor
"Breast cancer is a cancer that begins in the tissues of the breasts and progressively invades nearby tissues. Breast cancer typically affects older women, and it is much more common in women. It also tends to run a protracted course, which is why, in the final stages of the disease, it can also affect men and children." - Anonymous Online Contributor
"Current treatment options give cure rate estimates of up to 86% but this result is highly reliant on the patient selection and response to treatment. In an era where adjuvant treatment gives cure rate estimates of up to 84%, a higher cure rate of up to 85% would be highly probable with appropriate therapies." - Anonymous Online Contributor
"The symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can vary greatly among women, so some symptoms, such as a lump or discharge, can be inconsistent. For example, a lump on the right breast or nipple, which can be painful to touch, might be an early sign of breast cancer, but if the symptoms seem to be inconsistent with breast cancer, it is more likely to be a nipple discharge. Some other symptoms, such as a lump in the left breast or breast area would be more likely to be symptoms of breast cancer. Breast cancer can also include skin changes or sores." - Anonymous Online Contributor
"Survival rate varies considerably between the different countries. After controlling for pathological and biological characteristics, there were no significant differences in overall and breast cancer specific survival rates between Caucasian breast cancer patients from Norway, Canada, and the United States. Nevertheless, American patients had lower overall survival, probably in view of their higher nodal and distant metastases rate and age at diagnosis." - Anonymous Online Contributor
"In the absence of evidence to the contrary, we consider single agent PARP-inhibitors (e.g., AZD-8055) an effective drug to be used in any treatment regimen. However, there is no justification for using olaparib in the absence of other treatments, such as cisplatin." - Anonymous Online Contributor
"There have been major advances in understanding the molecular basis of cancer, which has led to increased understanding of the role of specific genes in the tumorigenic process, and new anti-tumor approaches that are currently evaluated in clinical trials. These have created significant opportunities for developing rational pharmaceutical agents for breast cancer. In the future, we anticipate that cancer gene therapy using siRNA that targets aberrant cancer genes will be more accurate to manage breast cancer and its associated risk of metastatic disease." - Anonymous Online Contributor
"Olaparib has been studied for several weeks in patients with advanced breast cancer. The FDA and EMA now both require New Drug Applications (NDA) for olaparib. The NDA requires an additional 6 months of preclinical data to test safety and efficacy of olaparib. The EMA also requires additional preclinical data for proof of concept of oParib to support the submission of a Marketing Authorization Application (MAA), and the EMA will provide a similar recommendation as the FDA. This may mean that the market for olaparib will be slower to commence in the EU than in the USA." - Anonymous Online Contributor
"It is imperative to note that olaparib does not treat [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The compound does not affect the development of cancer by itself. Rather, it acts by slowing down the spread of cancer cells. For this combination to be effective it may also be necessary to take other drugs such as cetuximab in conjunction with olaparib for a longer period. The mechanism to action of olaparib seems to be very similar to that of cisplatin, a chemotherapeutic drug used to treat bladder cancer." - Anonymous Online Contributor
"This is the first large clinical trial to demonstrate the therapeutic efficacy of olaparib. Results also support the hypothesis that PARP inhibition can improve OS even in patients with previously treated recurrence. Clin Cancer Res; 1-5. ©2015 AACR." - Anonymous Online Contributor