CLINICAL TRIAL

Pembrolizumab for Triple Negative Breast Neoplasms

Stage I
Waitlist Available · 18+ · Female · Overland Park, KS

This study is evaluating whether a combination of chemotherapy and an immune therapy may help treat triple-negative breast cancer.

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About the trial for Triple Negative Breast Neoplasms

Eligible Conditions
Breast Neoplasms · Triple Negative Breast Neoplasms · Triple-negative Breast Cancer

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab
DRUG
Carboplatin
DRUG
Docetaxel
DRUG
Pegfilgrastim
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Carboplatin
FDA approved
Docetaxel
FDA approved
Pegfilgrastim
FDA approved

Eligibility

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No previous chemotherapy, endocrine therapy, or radiation therapy has been given for this cancer with the intent of curing it. show original
The patient has not had any surgery on the same side of the body as the current breast cancer. show original
A person with ECOG performance status of 0 or 1 is generally considered to have a very good chance of surviving cancer. show original
Adequate cardiac function
The study's participants must be able to understand the study and must be willing to sign a written informed consent. show original
A patient with histologically confirmed stage I, II, or III TNBC is eligible for this study. show original
A woman who is not able to have children. show original
A woman who agrees to follow contraceptive guidelines. show original
Key
Adequate organ function
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Minimal residual disease (MRD) rate
UP TO 25 WEEKS
Defined as the percentage of patients with MRD, as evidenced by residual cancer burden (RCB) score of 0/1. Residual cancer burden score for each patient is calculated using surgical pathology parameters using an online tool (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3).
UP TO 25 WEEKS
Pathological complete response (pCR) rate
UP TO 25 WEEKS
Defined as the percentage of patients with PCR, as evidenced by absence of invasive disease in breast and axillary lymph nodes determined by histopathological examination.
UP TO 25 WEEKS
Recurrence-free survival (RFS)
UP TO 3 YEARS
Defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause.
UP TO 3 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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

Anonymous Patient Answer

What are the signs of triple negative breast neoplasms?

TNBC tumors commonly display a range of clinical characteristics, ranging from benign to malignant. TNBC tumors also display distinctive genetic alterations, such as TP53 mutations and epigenetic silencing of E-cadherin.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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%.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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