This trial is evaluating whether everolimus will improve 1 primary outcome and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of over 10 years.
This trial requires 1900 total participants across 2 different treatment groups
This trial involves 2 different treatments. Everolimus is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Approximately 275,000 new cases of breast cancer are diagnosed in the US each year. About 75,000 women in the US are diagnosed with breast cancer per year. Of the 275,000 cases of breast cancer in the US yearly, roughly 2,000 cases are reported fatal. About 1,200 deaths are reported yearly from breast cancer in the US. Approximately 50 cases will be diagnosed in Washington D.C. per year. About 25 cases of breast cancer will be diagnosed in Virginia each year. About 1,000 women will be diagnosed with breast cancer in Arkansas each year. About 100 cases will be diagnosed per year in Washington D.C. About 70 cases arise in Massachusetts. About 10 cases will be diagnosed in Texas.
Risk factors for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include nulliparity, breastfeeding, hormone imbalance and certain genetic mutations such as "BRCA 1 and BRCA 2". Most of breast cancer is not caused by genetic mutations though the tumour may develop at a rapid rate, which could be caused by hormonal imbalance, environmental conditions, and the presence of tumour suppressor genes. Breast cancer is currently treated by surgery, chemotherapy, and antiestrogen drugs. The most effective treatment is the combination of estrogen agonists with tamoxifen. While surgery may be considered in older women and women who are unfit for chemo or hormone therapy, there is no convincing evidence supporting aggressive surgery in younger women who are cured of breast cancer by surgery alone.
Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can be physical examination findings such as a palpable lump or a lump while breast-feeding, a mass in the axilla, discharge from the nipple, nipple retraction, and a family history of breast cancer. A physical examination of the abdomen or the pelvic area may reveal masses in the organs and may also show bowel obstruction. A colonoscopy may reveal masses (masses of colon cancer in the colon) which may compress the bowel.\n
Breast cancer is the most common type of cancer in women and the most common form of cancer overall in cancer centers that accept women in Massachusetts. In the US, breast cancer claims the life of at least one woman each day. The US incidence and mortality rates of breast cancer have risen steadily since their lowest values in 1969.
The only way for an individual to have a cure for their own [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is to eliminate the causative tumor and it's micro-metastases in all of the tissues that are under a woman's control. In fact, all women with early breast cancer are curable with early excisional surgery, which is curative in almost all cases. The disease, though, still can relapse after excision; the best method of avoiding a relapse is to use effective treatments, such as breast-conserving therapy (BCT) to remove the tumor and hopefully all local (within the breast tissue) micro-metastases, followed by adjuvant radiotherapy and chemotherapy, and/or endocrine therapy.
Everolimus, as a single agent and in combination with exemestane in patients with HR-positive locally advanced or metastatic ER/PR-positive tumors, did not demonstrate the effectiveness of everolimus for either progression-free survival or overall survival in two phase III trials (NCT00362968 and NCT00121684) at 16-month treatment completion. For patients with ER/PR-positive breast cancer treated with anastrozole plus exemestane for at least 12 months, everolimus was observed to have a significant impact on progression-free survival and is currently being studied in the HER2-expressing subgroup (NCT01159950).
After four months of everolimus or everolimus/exemestane, women are more likely to have a complete resolution of enlarged lymph nodes. They are also more likely to have a complete or partial response, as evidenced by a reduction in the size of or the number of residual lymph nodes by palpation. Patients who have a complete response (≥75% shrinkage in lymph nodes) derive a similar survival benefit when switching to everolimus. Additionally, after 10-12 weeks of everolimus, patients are more likely to have fewer residual lymph nodes compared with patients who receive placebo.
Among patients treated with everolimus, the most commonly reported side effect of everolimus is fatigue. Other commonly reported side effects include cough, anemia, hyponatremia, and decreased appetite. These side effects of everolimus seemed to occur at some point during everolimus therapy and were not serious.
While the current generation of treatments may not be an optimal option (particularly in the case of chemotherapy and newer therapies), and current clinical trials have not always reported results of superior effectiveness to treatment observed in the general population (especially in the case of aromatase inhibitors), there are numerous patients who suffer from the adverse effects of treatments and who wish to try alternatives. Because in most countries with sufficient resources, physicians have access to clinical trials comparing alternative therapies for the treatment of breast cancer, and because the results of clinical trials are published and available to other physicians, many patients use available information in order to make treatment choice. However, patients should be cautious in assessing the benefits and risks of clinical research prior to embarking on a clinical trial.
In order to summarize the most important information, I’ve listed the research we used in each category. Each time, I’m going to update the table. If you are a breast cancer patient you’re welcome to send me a message. If it doesn’t contain critical content please send me a picture and a message.\n
Although family history does occur in breast cancers, this is not a strong predictor of breast cancer risk. Genetic predisposition certainly plays a role, but in this small series, it did not account for the occurrence of more tumors, and the number was not statistically significant. Future studies examining this question should have higher confidence levels to overcome confounding factors.