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Chemotherapy

Pembrolizumab + Standard Therapy for Breast Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.

Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.

Must not have

Has a known history of active tuberculosis (Bacillus tuberculosis).

Has ER-, progesterone receptor positive breast cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 12 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether the cancer drug pembrolizumab is more effective than placebo when given with standard neoadjuvant and adjuvant therapy for high-risk early-stage ER+/HER2- breast cancer. The primary objectives are to compare pembrolizumab to placebo in terms of pathological complete response rate and event-free survival.

Who is the study for?

Adults with high-risk early-stage ER+/HER2- breast cancer, confirmed by a pathologist, who have not received prior treatment for it. Participants must have adequate organ function and an ECOG performance status of 0 or 1. Men and women must agree to use contraception during the study and for some time after. Exclusions include those with certain heart diseases, active infections like hepatitis B/C or tuberculosis, HIV, other cancers within the last five years (except specific non-invasive types), previous immunotherapy treatments, severe allergies to study drugs' components.

What is being tested?

The trial is testing pembrolizumab's effectiveness compared to a placebo when given alongside pre-surgery chemotherapy and post-surgery endocrine therapy in treating early-stage breast cancer. Success is measured by complete response rate at surgery and event-free survival rates.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), skin reactions, hormone gland problems (like thyroid disorders), infusion reactions; also possible are fatigue, nausea, blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use contraception and not donate sperm for up to 12 months after treatment.

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My breast cancer is ER positive, HER2 negative, Grade 3, and of ductal type.

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My breast cancer is invasive, not just on the surface, and is a certain size or has spread to nearby lymph nodes.

Exclusion Criteria

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

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I have an active tuberculosis infection.

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My breast cancer is estrogen receptor-negative and progesterone receptor-positive.

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I am currently being treated for an infection.

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I have or had lung inflammation treated with steroids.

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I have been treated with specific immune system drugs for cancer.

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I have more than one tumor in different areas of my breast.

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I have not needed strong medication for an autoimmune disease in the last 2 years.

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I have had a biopsy of my tumor or lymph nodes before starting the study treatment.

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I have cancer in both of my breasts.

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I have had serious heart issues, like a heart attack or heart failure, recently.

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I am on high-dose steroids or other drugs that weaken my immune system.

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My breast cancer has spread to nearby lymph nodes.

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My breast cancer has spread to other parts of my body.

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My breast cancer is of the lobular type.

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I have been diagnosed with HIV.

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I have a history of hepatitis B or an active hepatitis C infection.

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My heart's pumping ability is below normal.

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I have previously been treated for breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 12 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

Event-Free Survival (EFS)

Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0

Secondary study objectives

Change from Baseline in EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) Score

Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score

EFS in Participants With a CPS ≥1

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab+Chemotherapy (KX/KA[E]C)Experimental Treatment8 Interventions

In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

Group II: Placebo+Chemotherapy (PX/PA[E]C)Placebo Group7 Interventions

In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

Surgery

2000

Completed Phase 3

~2490