Active not recruitingPHASE2INTERVENTIONAL

Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer:

This research, called Neo-CheckRay, is for women aged 18 and over with a specific kind of breast cancer known as Luminal B. The study aims to find out if adding new drugs, durvalumab and oleclumab, to standard chemotherapy and radiation given before surgery, can improve treatment outcomes. Participants will be split into three groups: one receiving standard treatment, another getting standard treatment plus durvalumab, and a third group receiving standard treatment plus both durvalumab and oleclumab. Before the main study, a small group of six people will test the safety of the most comprehensive treatment. The goal is to see if these new combinations are safe and more effective.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Jules Bordet Institute

Enrolment target

147

Start

06 Nov 2019

Estimated completion

30 Sep 2029

Luminal B

What is this study about?

This study, called Neo-CheckRay, is looking into new ways to treat a specific type of breast cancer known as Luminal B. This kind of cancer has certain characteristics that doctors look at under a microscope, including how quickly the cells are growing.

The main idea behind this study is to combine treatments that are given before surgery. These treatments are chemotherapy (drugs that kill cancer cells), radiation therapy (using high-energy rays to shrink tumours), and two newer types of drugs called durvalumab and oleclumab. Doctors want to see if adding these newer drugs to standard chemotherapy and radiation can improve how well the treatment works to shrink the tumour before it's removed.

Participants in the study will be divided into three groups. One group will receive standard chemotherapy and a special kind of radiation to the tumour. The second group will get the same standard treatment plus durvalumab. The third group will receive all of these treatments, including both durvalumab and oleclumab. By comparing these groups, doctors hope to learn if these new combinations are better at treating Luminal B breast cancer.

Key takeaways

This study is for women with a specific type of breast cancer called Luminal B.
It combines chemotherapy, radiation, and potentially new drugs (durvalumab, oleclumab) before surgery.
Participants will be randomly assigned to one of three treatment groups.
The aim is to see if the new drug combinations are safer and more effective.
There's a small safety check before the main study starts.

Who may be eligible?

This study is for women who are at least 18 years old and weigh 35 kg (about 5 and a half stone) or more, and who are generally well enough to go about their daily life with little trouble.

To be considered for this study, you must have been diagnosed with a specific type of breast cancer called 'invasive breast adenocarcinoma'. Your cancer needs to be 'estrogen receptor-positive' and 'HER2-negative', which means certain tests on your tumour cells came back positive or negative. Also, your cancer cells must show signs of growing quickly (a high Ki67 score or Grade III).

Doctors will also review your tumour size (at least 2 cm if nearby lymph nodes aren't affected, or 1.5 cm if they are) and a special genetic test called MammaPrint, which helps understand your cancer's risk. You'll also need to agree to have new samples of your tumour taken for study purposes.

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 a woman aged 18 or older?
Do you have 'Luminal B' breast cancer (ER-positive, HER2-negative, and fast-growing)?
Are you generally well enough to manage daily activities?
Are you willing to provide new tissue samples from your tumour?
Has your tumour been assessed as 'high risk' by a MamaPrint test (or other specific criteria apply)?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will start with a small group of 6 people ensuring the safety of the most involved treatment. After this, if deemed safe, the main study begins. You will be assigned to one of three treatment groups. All groups will receive chemotherapy. This involves a drug called paclitaxel given weekly for 12 weeks, followed by another combination of drugs (doxorubicin and cyclophosphamide) given every two weeks for 8 weeks.

In addition to chemotherapy, you will also receive special radiation treatment to your tumour at week 5. Depending on which group you are in, you might also receive durvalumab (given every four weeks for 20 weeks) and/or oleclumab (given every two weeks for 8 weeks, then every four weeks for 12 weeks).

Throughout the treatment period, you will have regular visits to the clinic for treatments, check-ups, and to monitor your health. After completing these treatments, your tumour will be surgically removed within 2 to 6 weeks. The total duration of active treatment before surgery is several months, followed by your recovery from surgery and continued monitoring.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new treatments before they are widely available, and close monitoring of your health by a medical team. However, there are also potential risks, as the new drugs and combinations are still being studied, and their side effects might not be fully known. You might experience side effects from the chemotherapy, radiation, and the experimental drugs. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Institut Jules Bordet
Verified postcode
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Verified postcode
Brussels, Belgium
Universitaire Ziekenhuizen
Verified postcode
Leuven, Belgium
CHU UCL Namur Sainte-Elisabeth
Verified postcode
Namur, Belgium
GZA - Ziekenhuizen (Campus St. Augustinus)
Verified postcode
Wilrijk, Belgium
Centre Georges François Leclerc
Verified postcode
Dijon, France
Institut Curie
Verified postcode
Paris, France

Common questions

What is 'Luminal B' breast cancer?

It's a specific type of breast cancer that doctors identify by looking at certain features of the cancer cells under a microscope, including how quickly they are growing.

What is 'neo-adjuvant chemotherapy'?

This is chemotherapy given before surgery to shrink the tumour, which can sometimes make surgery easier or more effective.

What are durvalumab and oleclumab?

These are newer types of drugs called 'immunotherapies' or 'monoclonal antibodies' that help your body's immune system fight cancer.

Will I definitely receive the new drugs?

No, you will be randomly assigned to one of three groups. One group gets standard treatment, another gets standard treatment plus one new drug, and the third group gets standard treatment plus both new drugs.

What is the 'safety run-in' phase?

This is a small first step with 6 participants to make sure the most complex treatment combination is safe before the main study with more people begins.