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Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, NYBreast Cancer+2 MorePembrolizumab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether adding pembrolizumab and/or olaparib to standard radiation therapy can improve outcomes for patients with TNBC.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 8 weeks from baseline

8 weeks from baseline
Overall Response Rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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NG-350A plus Pembrolizumab
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Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%, Urinary tract infection with 100%.

Trial Design

4 Treatment Groups

Arm B
1 of 4
Arm A
1 of 4
Arm B (the study is amended to pause Arm B)
1 of 4
Arm C (activate new arm)
1 of 4

Experimental Treatment

34 Total Participants · 4 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Arm BExperimental Group · 2 Interventions: Radiation, Pembrolizumab · Intervention Types: Radiation, Drug
Arm AExperimental Group · 3 Interventions: Radiation, Pembrolizumab, Olaparib · Intervention Types: Radiation, Drug, Drug
Arm B (the study is amended to pause Arm B)Experimental Group · 2 Interventions: Radiation, Pembrolizumab · Intervention Types: Radiation, Drug
Arm C (activate new arm)Experimental Group · 3 Interventions: Radiation, Pembrolizumab, Olaparib · Intervention Types: Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2005
Completed Phase 3
~970
Pembrolizumab
FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks from baseline

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,847 Previous Clinical Trials
590,094 Total Patients Enrolled
193 Trials studying Breast Cancer
94,141 Patients Enrolled for Breast Cancer
Atif Khan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
91 Total Patients Enrolled
2 Trials studying Breast Cancer
91 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women who are 18 years or older and have been diagnosed with triple negative breast cancer or ER+/Her2 can participate in the study.
Your cancer cells will be tested to see if they have a protein called PD-L1. This can be tested on tissue samples from your primary or metastatic breast cancer. If your PD-L1 status is unknown, your archived tissue will be tested during screening.
You have triple-negative breast cancer, which means that the cancer cells do not have certain hormone receptors and protein markers.
You have breast cancer that has spread beyond the original site or has come back.
You are physically able to perform daily activities without any major limitations or require some assistance. A doctor will assess this within the month before the study starts.
You have breast cancer that has been confirmed by a laboratory test to have estrogen receptors (ER+) and does not have high levels of a protein called HER-2/neu.
You have triple-negative breast cancer that has spread or come back after previous treatment.
If you have metastatic triple-negative breast cancer, you cannot have received immunotherapy in the past without success and your tumor must test negative for a specific protein called PDL-1. For those with metastatic estrogen receptor-positive breast cancer, PDL-1 status is not used to determine eligibility.
You agree to participate in the trial and sign a paper saying you understand what it involves.
You have a tumor that can be measured and observed using imaging tests. The tumor must not be in the bone and must be able to be measured accurately.
References

Frequently Asked Questions

What are the approved indications for Pembrolizumab?

"Pembrolizumab is frequently used to treat patients with melanoma that cannot be surgically removed. It can also help those at high risk for recurrence or microsatellite instability disease." - Anonymous Online Contributor

Unverified Answer

How many people are taking part in this experiment at most?

"That is correct. The clinical trial, which has been recruiting since April 21st 2021, is looking for 34 patients to enroll at 7 different sites." - Anonymous Online Contributor

Unverified Answer

How many different research facilities are overseeing this experiment?

"There are 7 primary centres for this study, with Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale, Memorial Sloan Kettering Commack (Limited Protocol Activities) in Commack, and Memorial Sloan Kettering Cancer Center (All Protocol Activities) in New York being a few of them." - Anonymous Online Contributor

Unverified Answer

Are patients currently being recruited for this trial?

"Yes, the information available on clinicaltrials.gov indicates that this trial is still actively recruiting patients. The study was first posted on 4/21/2021 and has since been updated on 10/19/2022. Currently, the research team is looking for 34 individuals from 7 different centres." - Anonymous Online Contributor

Unverified Answer

Has this clinical trial been done before?

"Pembrolizumab has been the subject of 1162 studies since 2005, with the first being a Phase 1 drug approval stage study sponsored by AstraZeneca. This original trial had 98 participants and was conducted across 66 countries in 3072 cities. 377 follow-up studies have been completed." - Anonymous Online Contributor

Unverified Answer

When did the FDA last greenlight pembrolizumab?

"Pembrolizumab falls into the Phase 2 category, meaning that while there is some evidence pointing to its safety, there is none yet suggesting that it is an effective treatment. Our team at Power gave it a score of 2." - Anonymous Online Contributor

Unverified Answer

Are there Pembrolizumab studies that have been completed in the past?

"1162 clinical trials involving Pembrolizumab are ongoing. Of these, 143 have reached Phase 3 status. The majority of these studies are based out of Houston, Texas; however, there are 43122 different locations running Pembrolizumab trials." - Anonymous Online Contributor

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

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