CLINICAL TRIAL

Pembrolizumab for Triple Negative Breast Neoplasms

Locally Advanced
Metastatic
Refractory
Waitlist Available · 18+ · All Sexes · Chicago, IL

Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer

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About the trial for Triple Negative Breast Neoplasms

Eligible Conditions
Breast Cancer · Breast Neoplasms · 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.

Experimental Group 1
Pembrolizumab
DRUG
+
Mifepristone
DRUG
Experimental Group 2
Pembrolizumab
DRUG
+
Mifepristone
DRUG

About The Treatment

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

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
Common to both cohorts
Patients must have histologically confirmed breast cancer that is metastatic or locally advanced and unresectable.
Patients must have evaluable disease as defined by RECIST 1.1 with tumor lesion > 10 mm by CT scan or caliper measurement on clinical exam or lymph node ≥ 15mm in short axis.
ECOG performance status of 0 or 1.
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of pembrolizumab in combination with mifepristone in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
creatinine clearance ≥ 60 mL/min/1.73 m2
absolute neutrophil count ≥ 1,000/mcL
platelets ≥ 80,000/mcL
total bilirubin within normal institutional limits
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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 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..

Rate of overall response based on RECIST 1.1
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.
Determine the overall response rate (ORR) based on RECIST 1.1 of the combination of pembrolizumab and mifepristone in the different subtypes of breast cancer (hormone receptor positive and triple-negative)
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.
Rate of overall response based on irRECIST
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.
Determine the ORR based on irRECIST of the combination of pembrolizumab and mifepristone in the different subtypes of breast cancer (hormone receptor positive and triple-negative)
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.
Number of patients with adverse events
UP TO 3 YEARS
Determine the safety and tolerability of the combination of pembrolizumab and mifepristone
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.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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