This trial is evaluating whether Abemaciclib will improve 2 primary outcomes and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 1.5 years.
This trial requires 44 total participants across 2 different treatment groups
This trial involves 2 different treatments. Abemaciclib 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 1 & 2 and have already been tested with other people.
If breast cancer can be cured completely, the chances of cure will be higher because of early diagnosis, treatment and timely follow-up, then the treatment outcome will be better. Although the odds of complete cure may not be high, they can be increased if the breast cancer patient is detected for early detection, is tested and treated appropriately promptly.
Symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include a lump, nipple tenderness, a lump or abnormally shaped lump, the feeling that something is stuck or in the breasts, nipple irritation, breast pain or swelling, an unusually rapid or sudden onset of breast pain or bleeding. Most of these signs are not specific to breast cancer, but are common symptoms of other conditions common in women.
Breast cancer is a cancer that forms in the cells responsible for the formation of the breast. It begins within the walls of the breasts before invading them. Symptoms are rarely, if ever, found in early breast cancer. A lump in the breast is very often found on the first inspection; it is often more noticeable and may also be accompanied by a nipple that is inverted. A sore or scratch sensation can occasionally be felt. The general sensation might change or feel itchy or itchy might come and go, or a lump can persist for a duration. Older women in the 60s or 70s, or men in their 30s, have a greater chance of being diagnosed with late-stage breast cancer.
Treatment for breast cancer is often personalized and tailored to the specific staging of the disease. It has been estimated that 75% of all patients will receive surgery alone. The remainder will be treated with adjuvant therapies. The most common adjuvant therapies are chemotherapy (51%), monoclonal antibodies (25%), hormonal therapies (20%) and radiotherapy (7%), with combination therapy and neoadjuvant therapies being less common but growing in popularity. Survival times are much shorter for postmenopausal women as compared to premenopausal women.
Although women of all races, socioeconomic groups, and ethnic backgrounds are at risk, certain socioeconomic and geographic factors intensify the risk. A common risk factor for both breast and prostate cancer development seems to be cigarette smoking.
About 1.5 million women in the United States are diagnosed with breast cancer each year. This is about one third of the American women who have a primary breast cancer. The women with breast cancer receive nearly one-third fewer life years and half the total lifetime health care expenses.
There is little evidence supporting routine use of PIK3CA inhibitors across both first and second lines therapy of metastatic triple negative breast cancer. Clinical trials should continue to involve well-defined and well-defined chemotherapy regimens.
Almost all patients present and are treated in a tertiary institution. They present with locally advanced disease and are treated in a specialist department of gynaecology/surgery. The median follow-up time after diagnosis is 6 months (range: 1.6-11.8 months). The overall percentage of patients who are free of cancer disease at 1 year is 74.8% (range: 60.6-86.1%). The median time to tumour recurrence is 4 months (range: 1.9-6.8 months). The median time to death is 8.6 months (range: 3.8-12.7 months).
New drugs and therapies are slowly being introduced and reviewed to hopefully change the fate of women with primary breast cancer. The recent history of therapies and research is very rewarding but will not be ready in the present or the future. A new approach should be started and we need to realize we have a responsibility to help the women who already have had to suffer so much. This includes finding a way to find answers to the mysteries of breast cancer.
PIK3CA mutated breast cancer patients with abemaciclib are likely to have a higher objective response rate with abemaciclib treatment. Patients with BRCA1/2 mutation or HER2 amplification may benefit from this therapy. ClinicalTrials.gov identification number: NCT02254891.
In a retrospective analysis of 10 patients with metastatic breast cancer, abemaciclib was associated with a low rate of grade ≥2 neutropenia and mild skin reactions. The authors concluded that abemaciclib is safe for people. Clinicaltrials.gov ID: NCT02660232.
The majority of the Abemaciclib adverse events reported by patients were considered moderate or mild in severity. The most common abemaciclib-related adverse events were diarrhea and fatigue, both of which occurred in more than 5% of patients; nausea; headache, which occurred in more than 10% of patients; and hypotension, which occurred in more than 5% of patients. Other commonly reported adverse events included rash, dizziness, and nausea. Other uncommonly reported adverse events included blurred vision, fatigue, nausea, rash, and constipation.