Keynote 756

For patients with early stage ER+/HER2- breast cancer

Study Of Pembrolizumab Versus Placebo Plus Neoadjuvant Chemotherapy And Adjuvant Endocrine Therapy For The Treatment Of High-Risk, Early Stage Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational immunotherapy to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 50% will receive Pembrolizumab along with chemotherapy and maintenance endocrine therapy
  • 50% will receive placebo with chemotherapy and maintenance endocrine therapy


Trial Purpose
34

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT03725059 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

    Location
    Status
  • Daphne, Alabama, United States, 36526
    Recruiting
  • Goodyear, Arizona, United States, 85338
    Recruiting
  • Tucson, Arizona, United States, 85704
    Recruiting
  • Aurora, Colorado, United States, 80045
    Recruiting
  • Skokie, Illinois, United States, 60077
    Recruiting
  • Goshen, Indiana, United States, 46526
    Recruiting
  • Bethesda, Maryland, United States, 20817
    Recruiting
  • Omaha, Nebraska, United States, 68130
    Recruiting
  • Teaneck, New Jersey, United States, 07666
    Recruiting
  • Nashville, Tennessee, United States, 37203
    Recruiting
  • Austin, Texas, United States, 78731
    Recruiting
  • Dallas, Texas, United States, 75231
    Recruiting
  • Dallas, Texas, United States, 75246
    Recruiting
  • Plano, Texas, United States, 75075
    Recruiting
  • Tyler, Texas, United States, 75702
    Recruiting
  • Norfolk, Virginia, United States, 23502
    Recruiting
  • Kennewick, Washington, United States, 99336
    Recruiting
  • Spokane, Washington, United States, 99208
    Recruiting
  • Zion, Illinois, United States, 60099
    Recruiting
  • Waterloo, Iowa, United States, 50702
    Recruiting
  • Louisville, Kentucky, United States, 40202
    Recruiting
  • Tulsa, Oklahoma, United States, 74133
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19124
    Recruiting
  • Newnan, Georgia, United States, 30265
    Recruiting
  • Midlothian, Virginia, United States, 23114
    Recruiting
  • Billings, Montana, United States, 59102
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19111
    Recruiting
  • Mountain View, California, United States, 94040
    Recruiting
  • Tigard, Oregon, United States, 97223
    Recruiting
  • Sacramento, California, United States, 95817
    Recruiting
  • Boston, Massachusetts, United States, 02114
    Recruiting
  • New York, New York, United States, 10065
    Recruiting
  • Charleston, South Carolina, United States, 29425
    Recruiting
  • Jacksonville, Florida, United States, 32207
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-756

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.