Active not recruitingPHASE2INTERVENTIONAL

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

This study is looking into a new treatment called BNT327 for advanced breast cancer, specifically a type known as triple-negative breast cancer. Researchers want to find out if BNT327 is safe and effective when combined with standard chemotherapy drugs. This is a 'Phase II' study, which means it builds on earlier research and involves more people. Participants will be treated at different hospitals, and some will receive BNT327 alongside chemotherapy. The study aims to understand how BNT327 works in the body and if it can help people whose cancer has spread or is hard to treat. It's designed to find the best way to use this new drug combination.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

BioNTech SE

Enrolment target

Start

26 Aug 2024

Estimated completion

01 Jun 2029

Locally Advanced Breast Cancer Triple Negative Breast Cancer Metastatic Triple Negative Breast Cancers

What is this study about?

This study is exploring a new treatment for advanced breast cancer called BNT327. The type of breast cancer this study focuses on is known as triple-negative breast cancer, which can be more challenging to treat. When cancer is described as 'locally advanced,' it means it has grown into nearby tissues but hasn't spread to distant parts of the body. If it's 'metastatic,' it means the cancer has spread to other areas of the body. The main goal of this research is to see how safe BNT327 is and how well it works when given together with different chemotherapy drugs that are already used to treat breast cancer.

Researchers want to find the best dose of BNT327 to use and to see if this combination therapy can help patients. The study is divided into two main groups, called cohorts. In the first group, participants will be randomly assigned to receive one of two different doses of BNT327 along with a specific chemotherapy drug called Nab-paclitaxel. Once researchers figure out the most suitable dose from this first group, the second group will start.

In the second group, participants will receive the chosen dose of BNT327 with different chemotherapy drugs. This includes combinations with paclitaxel, or gemcitabine plus carboplatin, or eribulin. This approach helps the research team learn more about how BNT327 works with various existing treatments. The study aims to gather important information that could lead to new ways to treat triple-negative breast cancer in the future.

Key takeaways

This study is for advanced triple-negative breast cancer.
It's testing a new drug (BNT327) with standard chemotherapy.
The aim is to find out if the combination is safe and works well.
Participants will be closely monitored by medical staff.
It's a Phase II study, meaning it gathers more information on safety and effectiveness.

Who may be eligible?

This study is for adults aged 18 or older. To be considered, you must have advanced breast cancer that is inoperable (can't be removed by surgery) or has spread to other parts of the body. Your breast cancer must also be confirmed as 'triple-negative.' If you were previously diagnosed with another type of breast cancer, you'll need a new test to show your current cancer is triple-negative.

If you haven't had any treatment for your advanced or metastatic breast cancer yet, you might be eligible if at least six months have passed since your last treatment for earlier-stage breast cancer (if you had any). If you've already had one chemotherapy treatment for your advanced breast cancer and it's stopped working, you might also be able to join. You need to be willing and able to attend all appointments, follow the treatment plan, and complete any study tasks, like filling in diaries.

Quick self-check

Are you 18 years old or older?
Has your breast cancer been diagnosed as locally advanced or metastatic (spread)?
Is your breast cancer confirmed as 'triple-negative'?
Have you had no prior treatment for your advanced cancer, or only one previous chemotherapy that has stopped working?
Are you willing and able to attend all study appointments and follow the treatment plan?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue treatment until your cancer shows signs of getting worse, you experience side effects that are too difficult to manage, you decide to stop, the study ends, or for up to two years, whichever comes first. You’ll have regular visits for check-ups and to review your health. The specific tests will include blood tests, scans, and other assessments to see how you are responding to the treatment and to monitor for any side effects.

The study involves different types of chemotherapy drugs (like Nab-paclitaxel, Carboplatin, Gemcitabine, Paclitaxel, Eribulin) given in combination with the new drug BNT327. Depending on which group you are assigned to, you will receive BNT327 at a specific dose, either in combination with Nab-paclitaxel first, or later with other chemotherapy drugs such as paclitaxel, gemcitabine plus carboplatin, or eribulin. The doctors will monitor you closely throughout the study.

Potential risks and benefits

Participating in a clinical trial offers the chance to receive a new, experimental treatment that might be more effective than current options, and you'll receive very careful medical monitoring. However, there's no guarantee the treatment will work for you, and like all medications, BNT327 and the chemotherapy drugs have potential side effects, which could be serious. The research team will explain all the known risks before you make a decision. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

Beverly Hills Cancer Center
Beverly Hills, United States
Valkyrie Clinical Trials
Los Angeles, United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
Palo Alto, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, United States
Rocky Mountain Cancer Centers (RMCC)
Denver, United States
Yale University - Yale Cancer Center
New Haven, United States
Carle Foundation Hospital d/b/a Carle Cancer Center
Urbana, United States
HealthPartners Regions Specialty Clinics
Saint Louis Park, United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)
New Brunswick, United States
Stony Brook University Hospital
Stony Brook, United States
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, United States
SCRI Oncology Partners
Nashville, United States

+19 more sites — see the official record for the full list.

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer is a type of breast cancer where the cancer cells don't have certain receptors (oestrogen, progesterone, and HER2). This means it doesn't respond to hormone therapy or HER2-targeted drugs, requiring different treatment approaches.

What does 'Phase II' mean for a clinical trial?

Phase II trials look at whether a new treatment works and is safe in a larger group of people than in earlier phases. Researchers also try to find the best dose and how well it controls the disease.

Will I know which treatment I'm getting?

This is an 'open-label' study, which means if you participate, you and your doctor will know which combination treatment you are receiving.

How long will I be on the study treatment?

You will receive the study treatment for up to two years, or until your cancer gets worse, you have serious side effects, or you decide to stop.

What happens after the study ends?

Once the study treatment stops, your medical team will discuss the next steps for your care, which will be part of your ongoing treatment plan.