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Checkpoint Inhibitor

Pembrolizumab for Triple-Negative Breast Cancer

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estrogen (ER) and progesterone (PR) =< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence in situ hybridization [FISH])
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy should have been completed preoperatively
Must not have
No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product
No evidence of recurrent disease following preoperative therapy and surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will study if immunotherapy with pembrolizumab can help prevent the return of triple-negative breast cancer after preoperative chemotherapy.

Who is the study for?
This trial is for adults over 18 with early-stage triple-negative breast cancer who had no invasive disease after preoperative chemo and pembrolizumab. They must have completed at least 6 cycles of this treatment, be HIV-positive on effective therapy if applicable, not pregnant or nursing, and without severe active liver disease or a history of certain heart conditions.
What is being tested?
The study compares the effects of continuing pembrolizumab to just observation in patients who've had a complete response to initial treatment. It aims to see if further immunotherapy reduces the risk of cancer returning compared to monitoring without additional drug intervention.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, potential infusion reactions (like allergic responses during administration), fatigue, skin issues, hormonal gland problems like thyroid dysfunction, and could possibly worsen existing infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is mostly not driven by estrogen or progesterone and is not HER2 positive.
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I completed at least 6 cycles of chemotherapy with pembrolizumab before surgery.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My breast cancer was stage T1cN1-2 or T2-4N0-2 according to AJCC 8th edition.
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My last surgery was no more than 12 weeks ago.
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All visible cancer was removed from my breast and lymph nodes through surgery.
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I am not currently using any experimental cancer treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had a severe allergic reaction to pembrolizumab or similar medications.
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My cancer has not come back after initial treatment and surgery.
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I do not have any active liver diseases like hepatitis or autoimmune disorders.
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I haven't needed strong immune system-suppressing drugs in the last 2 years.
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My breast cancer has not spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-free survival (RFS)
Secondary study objectives
Incidence of adverse events (AEs)
Locoregional recurrence incidence
Overall survival
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (observation)Experimental Treatment5 Interventions
Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Group II: Arm I (pembrolizumab)Active Control5 Interventions
Patients receive pembrolizumab IV on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Biopsy
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,110,813 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
518 Previous Clinical Trials
221,042 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05812807 — Phase 3
Breast Cancer Research Study Groups: Arm II (observation), Arm I (pembrolizumab)
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05812807 — Phase 3
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05812807 — Phase 3
~863 spots leftby May 2033
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