Pembrolizumab for Triple Negative Breast Neoplasms
Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer
See full descriptionAbout the trial for Triple Negative Breast Neoplasms
Treatment Groups
This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 2 secondary outcomes in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of From the time of first documented complete response or appearance of one or more new lesions, until the first documented date of recurrent or progressive disease, whichever came first, assessed up to 100 months..
Patient Q & A Section
Can triple negative breast neoplasms be cured?
The first-line treatment for TNBC is surgery; when not possible, adjuvant treatment with either chemotherapy or endocrine therapy (HR-positive and low Ki67 or estrogen receptor) may be considered.
What are common treatments for triple negative breast neoplasms?
Most women with TNBCs underwent surgery followed by adjuvant chemotherapy. Recent findings of this study suggest that women with TNBC, especially those whose tumors overexpress the PI3K/Akt pathway, could benefit from anti-hormone therapy in addition to local therapy.
What are the signs of triple negative breast neoplasms?
TNBC patients may have a palpable mass, nipple retraction, non-palpable, or lymphedematous skin changes or telangiectasias, and palpable or palpable-nonpalpable lymph node enlargition and an increased axillary Dye-Sofn Score, and axillary calcification.
What is triple negative breast neoplasms?
The term triple negative breast neoplasms is most commonly used as a synonym to triple negative breast cancer, but its use is not supported by data showing prognostic information. The expression profile and molecular characteristics of triple negative breast cancer differ with their aggressiveness.
What causes triple negative breast neoplasms?
In breast cancer, intrinsic TNBCs may develop by mechanisms different from PNBCs, which may have different causes and more aggressive features. Targeting tumors of known genetic alterations, such as BRCA1/BRCA2, may be indicated in TNBC.
How many people get triple negative breast neoplasms a year in the United States?
Overall the incidence of TNBC is 10.3 per 100,000 per year and the mortality rate is 5.3 per 100,000 per year. The incidence is greater among black women. In the absence of clinical trials for TNBC the most prudent approach is to recommend breast screening with the intent of early detection of the disease. This article is protected by copyright. All rights reserved.
Have there been other clinical trials involving pembrolizumab?
There was a pembrolizumab clinical trial with patients that were enrolled after they experienced a primary or metastatic cancer recurrence. Patients were randomized to take either pembrolizumab or placebo. This trial was completed in 2010. The interim report was published in the Journal of Clinical Oncology in 2011. There was a clinical trial by the National Cancer Institute comparing the monoclonal antibody to dactinib, in people that did or did not have certain molecular genetic alterations and in people who either had previous or new onset glioblastoma multiforme, but did not, or did not, have it.
What is the survival rate for triple negative breast neoplasms?
There is a significant difference in survival between patients with TNBC and other breast cancers based upon estrogen receptor expression and p53 mutation status. There is also a survival difference between patients that have received adjuvant treatment and patients that have not.
What is pembrolizumab?
pembrolizumab is effective in patients with triple-negative breast cancer. Patients who received at least one cycle of pembrolizumab-based therapy had a significantly longer time to progressive disease compared with patients who underwent anthracycline-containing chemotherapy.
What is the average age someone gets triple negative breast neoplasms?
The average incidence of triple negative breast neoplasm is 70.3 per 100,000. A diagnosis of triple negative breast neoplasm should not be made unless there is no other possibility for a primary neoplasm, as it leads to long term harm caused by subsequent treatment.
Have there been any new discoveries for treating triple negative breast neoplasms?
There have been several new treatments for triple negative and [other types of negative [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)]. [Intrastromal cytotoxin-α, (ILC-A)((DDP-A)(Oriol15-monomethylcarbamoylacetate-α,β-dihydroorotate) has been used successfully in treating triple negative and other types of breast cancer cells. Although this chemotherapeutic agent has had limited success in clinical trials, it works by interfering with DNA replication, which is most commonly the cause of cell death in cancer cells. (https://ncmap.ncbi.nlm.nih.gov/books/NBK.
What are the common side effects of pembrolizumab?
In this exploratory multicenter study, it was found that the most frequently observed adverse events included fatigue, nausea, dyspnoea, pneumonitis, and dyspnoea. Other frequently occurring events were rash, peripheral neuropathy, constipation, diarrhoea and joint pain. Because of the small number of patients, these results need to be taken with serious caveats.