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Pembrolizumab for Triple-Negative Breast Cancer

Phase 3

Waitlist Available

Led By Lajos Pusztai

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have metastatic disease (i.e., must be clinically M0 or Mx)

Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol

Must not have

Patients must not have locally recurrent disease

Patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial studies pembrolizumab to see how well it works in treating triple-negative breast cancer.

Who is the study for?

This trial is for adults with triple-negative breast cancer who've completed neoadjuvant chemotherapy and surgery, have no metastatic or recurrent disease, and no active hepatitis or infections. They must not be pregnant/nursing, have had certain prior treatments (like anti-HER2 therapies), live vaccines recently, or autoimmune diseases treated in the last 2 years.

What is being tested?

The study tests Pembrolizumab as an additional treatment after standard therapy for triple-negative breast cancer. It's a phase III trial to see if this immunotherapy can prevent cancer from returning by helping the immune system attack remaining cancer cells.

What are the potential side effects?

Pembrolizumab may cause side effects like fatigue, skin reactions, inflammation of organs such as lungs (pneumonitis), hormonal gland problems (thyroid issues), infusion-related reactions, and it could potentially worsen autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread to distant parts of my body.

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I am not planning to undergo any other cancer treatments except radiation while on this trial.

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I had a full medical check-up in the last 28 days.

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My kidney function is normal or near normal.

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I do not have an infection that needs treatment with medication.

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My cancer has not spread to distant parts of my body and has not come back in the same place.

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My breast cancer is triple-negative or has low hormone receptor levels.

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I haven't and won't receive HER2 or hormone therapy after initial chemo.

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I have at least 5 tissue slides from my cancer available for testing.

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I had chemotherapy before surgery to shrink my tumor.

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I can take care of myself but might not be able to do heavy physical work.

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I haven't needed steroids for lung inflammation in the last 2 years.

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I do not have an active hepatitis B or C infection.

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I am 18 years old or older.

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I had cancer cells in my underarm lymph nodes confirmed before treatment and only one sentinel lymph node removed after.

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I have never received immunotherapy treatments like anti-PD-L1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has not returned in the same place it was treated.

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I am not planning to take any treatments not allowed in the study.

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I am not HER2-positive according to specific cancer guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

Invasive disease-free survival (IDFS)

Physical function

Severity of fatigue

Secondary study objectives

Distant recurrence-free survival (DRFS)

Emotional function and disease-related symptoms in patients receiving pembrolizumab

Impact of treatment and treatment-related symptoms on physical function in patients without therapy

+8 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

Group I: Arm II (pembrolizumab)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 30 minutes on days 1 and 22. Cycles repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Patients may also undergo collection of blood samples throughout the trial.

Group II: Arm I (observation)Experimental Treatment6 Interventions

Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Patients may also undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Pembrolizumab

2017

Completed Phase 3

~2810