This trial is evaluating whether Abemaciclib will improve 12 primary outcomes and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of From Baseline until 30 days after the last dose of study drug (up to 6 years).
This trial requires 415 total participants across 11 different treatment groups
This trial involves 11 different treatments. Abemaciclib is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Symptoms in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) may include breast lump, axillary or groin lymphadenopathy, or an irregular mass in the breast or in one of the chest pockets. Breast cancer can also present with nipple discharge and the redness and swollen of the breast. In general, symptoms are more common in women with late-stage disease. Breast cancer can usually be diagnosed clinically based on the presence of the signs above, or through screening. In some cases, a breast lump may be suggestive of breast cancer if it is palpable and does not disappear during a breast self examination. There are several treatments for breast cancer, including surgery, chemotherapy, hormonal therapy or other interventions.
There are reasons to believe that [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can be cured with optimal tumour resection and adjuvant systemic chemotherapy. However, the possibility remains forever that some breast cancers which are amenable to surgery will recur, and that in some patients breast cancer will have a fatal outcome, either due to cancer cells which have escaped surgical removal or to the effects of adjuvant chemotherapy that kills cancer cells in addition to the tumour. Patients should therefore be encouraged to take decisions with which they are willing to live.
Although a minority of the total [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) population, women in the SEP and women not receiving mammography every 3 years constitute a very large fraction of new cancer diagnoses. Breast cancer has a wide burden among the population. It is important that the public be aware of these data to understand cancer prevention.
The cause of breast cancer is not understood, but it is likely connected to a wide range of environmental factors including lifestyle, environment, family history of breast cancer, and genetics. As environmental risk factors for breast cancer become better defined, it is hoped that our understanding will be improved, and more effective programs can be developed.
Breast cancer, a life-threatening cancer, is a chronic, life-changing illness that impacts an individual's quality of life, can be treated, and in some cases is prevented. The symptoms of breast cancer onset, and the indicators and effects that symptomology produces in women are very diverse and vary from woman to woman. This is especially true for those who are newly diagnosed. Symptoms can develop very quickly or they can mimic other common conditions. This variability in symptoms and the inability to predict when women will develop breast cancer means that women may feel unwell for long periods of time. If a woman is diagnosed with breast cancer it is very important for her and her family to be aware that the symptoms may be different each time.
Among the medications used for the treatment of [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer), tamoxifen, letrozole, cyclophosphamide, doxorubicin, trastuzumab and taxanes. Chemotherapeutic medicines used for treatment of breast cancer can be divided into chemotherapy drugs, antiestrogens, monoclonal antibody, and HER-2 antagonists.
The vast majority of breast cancer cases, more than 85% in this study, spread within 15 years of diagnosis to other locations in the body, with the most common being to the lungs and the bone\n\n2. Joan Rivers. Joan Rivers was diagnosed with breast cancer in 1995. Two more diagnoses would follow, including a triple-Negative Breast Cancer (TNBC, which is rarely found outside of East Africa and New Zealand). Her fight went on for nearly 20 years until she died, at the age of 60, from what was found to be Non-Hodgkin's lymphoma, another TNBC.
Breast cancer is a serious disease even among those who are very young. The average age at which breast cancer was diagnosed in our population is 47.
These data suggest that AIs are effective and that they increase the duration of PFS in HER2 positive breast cancer relative to taxane. Furthermore, the combination of AIs and chemotherapy may increase the duration of PFS of HER2-positive breast cancer relative to chemotherapy. Findings from a recent study suggests that abemaciclib is effective in patients with HER2+/neu+ with metastatic breast cancer.
Abemaciclib has an excellent safety profile with no appreciable changes observed in circulating or urine biomarkers during the studies. The most common side effects of abemaciclib were diarrhoea, dizziness, headache, nausea, abdominal pain, fatigue, weakness, rash, alopecia, skin irritation and vomiting.
Clinically, abemaciclib monotherapy induces tumor growth inhibition in HER2+ breast cancers as demonstrated by the fact that treatment does not lead to any new recurrences for patients with HER2+ tumors after 2 to 4 years follow-up.
Findings from a recent study shows that there was little significant difference in the age of when breast cancer diagnosed for male vs. female patients. A larger retrospective study is needed to determine the average age at diagnosis with regard to male vs. female patients.