Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
National Cancer Centre Singapore ( Site 2600), Singapore, SingaporeBreast CancerPembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment of pembrolizumab (MK-3475) combined with chemotherapy vs. chemotherapy alone in participants who have triple negative breast cancer.

Eligible Conditions
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to approximately 8 years

Week 30
EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score
Breast
pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery
pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery
pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Week 57
Percentage of participants who discontinue study treatment due to an AE
Week 61
Percentage of participants who experience an adverse event (AE)
Year 8
EFS in participants with tumors expressing PD-L1
Event-free Survival (EFS) as assessed by Investigator
Overall survival (OS)

Trial Safety

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

2 Treatment Groups

Placebo + Chemotherapy
1 of 2
Pembrolizumab + Chemotherapy
1 of 2

Active Control

Experimental Treatment

1174 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 3

Pembrolizumab + ChemotherapyExperimental Group · 7 Interventions: Cyclophosphamide, Carboplatin, Epirubicin, Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim, Pembrolizumab, Paclitaxel, Doxorubicin · Intervention Types: Drug, Drug, Drug, Biological, Biological, Drug, Drug
Placebo + ChemotherapyActiveComparator Group · 7 Interventions: Placebo, Cyclophosphamide, Carboplatin, Epirubicin, Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim, Paclitaxel, Doxorubicin · Intervention Types: Drug, Drug, Drug, Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Carboplatin
FDA approved
Epirubicin
FDA approved
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 8 years

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,150 Total Patients Enrolled
18 Trials studying Breast Cancer
5,560 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,711 Previous Clinical Trials
4,966,524 Total Patients Enrolled
54 Trials studying Breast Cancer
7,183 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,656 Previous Clinical Trials
7,956,430 Total Patients Enrolled
7 Trials studying Breast Cancer
1,733 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Virginia50.0%
Michigan50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

What are the research objectives of this clinical trial?

"The primary outcome of this clinical trial is Event-free Survival (EFS) as assessed by Investigator, which will be evaluated over a Up to approximately 27-30 weeks time frame. Secondary outcomes include pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed" - Anonymous Online Contributor

Unverified Answer

Is it possible to sign up for this experiment right now?

"This research is not currently enrolling new patients. The study was originally posted on March 7th, 2017 and last updated on July 8th, 2022. However, there are 2436 other trials related to triple negative breast neoplasms that are actively recruiting and 2979 for Pembrolizumab if you're interested in participating in active clinical trials." - Anonymous Online Contributor

Unverified Answer

Is this a new clinical trial?

"Since 1997, when the first study occurred in sponsored by Alfacell, Pembrolizumab has been researched. The drug went through Phase 3 approval after the initial 300-person trial in 1997. As of now, there are 2979 active studies involving Pembrolizumab across 4472 cities and 88 countries." - Anonymous Online Contributor

Unverified Answer

How many locations are conducting this research?

"Presently, patients are being accepted at Christiana Hospital (Site 0029) in Newark, Delaware; Nyack Hospital Infusion Center (Site 0059) in Nyack, New York; Oncology Hematology Care, Inc. (Site 8011) in Cincinnati, Ohio; and 54 other locations." - Anonymous Online Contributor

Unverified Answer

What is the standard Pembrolizumab dosage for patients?

"Pembrolizumab, while most commonly used to treat melanoma, can also help patients suffering from neoplasm metastasis, malignant melanoma of skin, and corticotropin." - Anonymous Online Contributor

Unverified Answer

How many people are in this experiment?

"This particular study is no longer looking for patients to enroll. However, there are 2436 trials currently recruiting patients with triple negative breast neoplasms and 2979 trials actively recruiting patients that hope to receive Pembrolizumab." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab been cleared for therapeutic use in the United States?

"The safety of Pembrolizumab is thought to be high as it is a Phase 3 trial, meaning there is both evidence of efficacy and multiple rounds data supporting safety." - Anonymous Online Contributor

Unverified Answer

What other types of research has been conducted using Pembrolizumab?

"Pembrolizumab was first studied in 1997 at Spectrum Health Hospital - Butterworth Campus. 21532 trials have been completed to date, with 2979 active clinical trials presently underway - many of which are based in Newark, Delaware." - 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.