Pembrolizumab for Triple Negative Breast Neoplasms
This study is evaluating whether a combination of chemotherapy and an immune therapy may help treat triple-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 all receive the same treatment. 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 female patients 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 Up to 25 weeks.
Patient Q & A Section
How many people get triple negative breast neoplasms a year in the United States?
Over 3 million neoplasms of the breast in US population will be diagnosed in 2019. This means that 2.3 new cases will be diagnosed per 100,000 women per year.\n
Can triple negative breast neoplasms be cured?
There is no evidence for cure for triple negative breast cancers. There would not be any long-term benefit for patients in the event of long-term survival due to an effective and durable response, as in BRCA carriers.
What is triple negative breast neoplasms?
TNBC is a heterogeneous group of breast neoplasms, characterized by the lack of expression of estrogen receptor (ER), progesterone receptor (PR) and/or HER2/neu. The clinical relevance and heterogeneity of this tumor subtype still remains unclear, although it is thought that the high propensity to metastasize and a probable link between this tumor subtype and the poorer prognosis of patients with breast cancer were discussed.
What are common treatments for triple negative breast neoplasms?
This report illustrates the frequent use of chemotherapy, hormone therapy and surgery to treat [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer)s. A combination of clinical expertise and the most current guidelines is needed to improve the management of this breast cancer subset.
What causes triple negative breast neoplasms?
It is suggested that the pathogenesis of triple negative breast cancer is complex, but that one mechanism is a deficiency in one or more tumor suppressor genes. It appears that the tumor suppressor BRCA1 is often deficient in combination with several other genes in triple negative breast cancer.
Has pembrolizumab proven to be more effective than a placebo?
Pembrolizumab therapy is associated with prolonged TTP and decreased EFS regardless of HER2 overexpression or other intrinsic molecular characteristics of breast cancer cells. However, this is not true of the control group, in which chemotherapy has no effect without chemotherapy. This observation suggests that the action of a first-line checkpoint inhibitor like pembrolizumab will be a more effective adjuvant treatment for breast cancer in a subset of patients who would not benefit from chemotherapy alone but may benefit from the treatment's intrinsic and anti-tumor immune mechanism even if HER2 overexpression is present.
How serious can triple negative breast neoplasms be?
In our experience, the dismal prognosis associated with TNBC and the increased risk of metastasis after diagnosis must not be underestimated. Appropriateness of surgical approaches has an important impact on survival.
Who should consider clinical trials for triple negative breast neoplasms?
We can recommend clinical trials for all TNBCs based on the evidence of these publications. The presence of lymph node involvement, a high tumoral burden, and younger age seem to be negative prognostic factors. The use of TNBCs should be considered in the treatment of patients with breast Cancer.
What are the latest developments in pembrolizumab for therapeutic use?
Pembrolizumab has progressed through both large and smaller Phase III trial studies. At least six studies have demonstrated pembrolizumab's superiority to placebo, and its safety is well understood at this point. Further research efforts will clarify the optimal use and duration of pembrolizumab.
What is the survival rate for triple negative breast neoplasms?
The prognosis for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) patients with triple negative breast neoplasm is poor. One-third of them will develop metastasis, and 15% will die of the disease after the first diagnosis. Survival rate among patients with TNBC is approximately 40%.
What is pembrolizumab?
Adding pembrolizumab to anthracycline and taxane-based chemotherapy did not improve the efficacy or improve progression-free or overall survival of breast cancer patients with HER2/neu amplification. Pembrolizumab had a well-tolerated safety profile and showed an acceptable therapeutic index.