Active not recruitingPHASE3INTERVENTIONAL

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

This study, called KEYNOTE-756, is testing a medicine called pembrolizumab alongside standard treatments for early-stage breast cancer. It's for adults with a particular type of breast cancer known as ER-positive, HER2-negative (ER+/HER2-), which is grade 3 and considered high-risk. Participants will receive chemotherapy before surgery, followed by surgery, and then more treatment including the study drug and hormone therapy. The main goal is to see if adding pembrolizumab helps to shrink the cancer more before surgery and if it helps people live longer without the cancer returning, compared to a dummy drug (placebo). This is a Phase 3 study, meaning it's comparing the new treatment to the best current standard care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

1,240

Start

27 Dec 2018

Estimated completion

24 Jan 2031

Breast Cancer

What is this study about?

This important study is investigating a new approach to treating early-stage breast cancer. The specific type of breast cancer being studied is called ER-positive, HER2-negative, which means the cancer cells grow in response to hormones and don't have high levels of a protein called HER2. In this trial, researchers are combining a new drug called pembrolizumab with the standard treatments you would normally receive, such as chemotherapy before surgery and hormone therapy after surgery.

The main idea behind this study is to find out if adding pembrolizumab can make standard treatments even more effective. They want to see if it helps shrink the tumour more before surgery, which doctors call a 'pathological complete response'. They also want to understand if it helps people live longer without their cancer coming back, which is known as 'event-free survival'. By comparing pembrolizumab to a placebo (a dummy drug), scientists can accurately tell if pembrolizumab is truly making a difference.

This is a Phase 3 study, which means it's one of the final steps in testing a new treatment. It involves a larger number of people and aims to confirm if the new treatment is safe and more effective than existing options. This research is crucial for developing potentially better ways to treat early-stage breast cancer and improve outcomes for patients.

Key takeaways

This study tests if a new drug, pembrolizumab, improves breast cancer treatment.
It's for early-stage, ER-positive, HER2-negative breast cancer.
Pembrolizumab is given with standard chemotherapy and hormone therapy.
Researchers want to see if it shrinks tumours more and prevents cancer recurrence.
Participation involves treatment before and after surgery, spread over about a year.
It is a Phase 3 trial, comparing the new drug to a dummy drug (placebo).

Who may be eligible?

To join this study, you would generally need to be an adult with a specific type of breast cancer that hasn't spread to other parts of your body (early-stage). Your cancer cells must be ER-positive and HER2-negative, and it needs to be Grade 3. Doctors will also check the size of your tumour or if it has spread to nearby lymph nodes.

You would need to be well enough to take part, with good general health and normal organ function. Both men and women can join, but if you're taking part, you'd need to use effective birth control throughout the study treatment and for a period afterwards.

However, you wouldn't be able to join if your breast cancer has spread to other parts of your body (Stage IV), or if you have a specific type of breast cancer called lobular histology. Also, if you’ve had certain lung conditions in the past, or if you have multiple tumours in different locations in the same breast, you might not be eligible. The care team will discuss all the detailed criteria with you to see if this study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Do you have early-stage breast cancer (not spread to distant parts of the body)?
Has your doctor confirmed your breast cancer is ER-positive and HER2-negative, and Grade 3?
Are you generally well and fit enough for treatment, with good organ function?
Are you able to use reliable birth control during and after the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll start with a series of chemotherapy treatments over about five months (8 cycles, each lasting 21 days). During this time, you'll also receive either the study drug, pembrolizumab, or a placebo (dummy drug). After these initial treatments, you will have surgery for your breast cancer. Following surgery, you will continue with the study drug (or placebo) for another 9 cycles, which will take around six months. For up to 10 years after that, you will receive hormone therapy, which is a standard long-term treatment for this type of breast cancer. Throughout the study, you'll have regular appointments to monitor your health and how you're responding to treatment.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to a new treatment before it's widely available and extra monitoring during your care. However, there are also potential risks, including side effects from the study drug or other treatments, which can vary from mild to more serious. It's important to remember that the new treatment might not work for everyone, or it might not be better than standard care. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (244)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Southern Cancer Center, PC ( Site 8003)
Verified postcode
Daphne, United States
Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)
Verified postcode
Goodyear, United States
Arizona Oncology Associates PC- HOPE ( Site 8008)
Verified postcode
Tucson, United States
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)
Verified postcode
Los Angeles, United States
El Camino Hospital Cancer Center ( Site 0004)
Verified postcode
Mountain View, United States
Stanford Cancer Center ( Site 0072)
Verified postcode
Palo Alto, United States
UC Davis Comprehensive Cancer Center ( Site 0073)
Verified postcode
Sacramento, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0008)
Verified postcode
Aurora, United States
Baptist MD Anderson Cancer Center ( Site 0014)
Verified postcode
Jacksonville, United States
Southeastern Regional Medical Center, Inc. ( Site 0075)
Verified postcode
Newnan, United States
The University of Chicago Medical Center ( Site 0080)
Verified postcode
Chicago, United States
Orchard Healthcare Research Inc. ( Site 0020)
Verified postcode
Skokie, United States

Common questions

What is pembrolizumab?

Pembrolizumab is a type of immunotherapy drug that helps your body's immune system fight cancer cells more effectively.

What does ER+/HER2- mean?

This describes a specific type of breast cancer where the cancer cells are sensitive to hormones (ER-positive) but do not have too much of a protein called HER2 (HER2-negative).

What is a 'placebo'?

A placebo is an inactive substance or treatment that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects.

What is 'neoadjuvant' and 'adjuvant' therapy?

Neoadjuvant therapy is treatment given before surgery, often to shrink the tumour. Adjuvant therapy is given after surgery, to help prevent the cancer from coming back.

How long will I be in this study?

The active treatment phase, including chemotherapy and the study drug around surgery, lasts for about 11 months. You will then continue with hormone therapy for up to 10 years.