Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomised phase II trial evaluating the efficacy of a nivolumab monotherapy lead in “window” or commencement of nivolumab concurrently with paclitaxel and carboplatin as neoadjuvant therapy in early stage triple negative breast cancers

This clinical trial is designed for people with early-stage triple-negative breast cancer. Researchers are exploring if adding a new drug, nivolumab (also known as OPDIVO), to standard chemotherapy (paclitaxel and carboplatin) can improve treatment. They want to see if this combination helps shrink the cancer more effectively before surgery. The study has two main groups: one where nivolumab is given briefly before chemotherapy, and another where it's given at the same time. The main goal is to find out if the cancer completely disappears from the breast and lymph nodes after this treatment. This research aims to find better ways to treat this specific type of breast cancer, potentially leading to more successful outcomes for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

ANZ Breast Cancer Trials Group Limited

Enrolment target

Start

22 Jul 2024

Early stage triple negative breast cancer

What is this study about?

This clinical trial is for people in the UK who have been diagnosed with early-stage triple-negative breast cancer. This type of breast cancer is known to be more aggressive and harder to treat than other types, as it doesn't respond to some common treatments like hormone therapy or drugs that target HER2 protein. That's why doctors are always looking for new and better ways to treat it.

The study is investigating a new drug called nivolumab (brand name OPDIVO) in combination with standard chemotherapy. Nivolumab is an immunotherapy drug. This means it works by helping your body's own immune system find and fight cancer cells. The 'early stage' part means the cancer hasn't spread widely in the body.

Researchers want to see if adding nivolumab to chemotherapy, either as a short 'starter' treatment before chemotherapy or given at the same time as chemotherapy, makes the cancer shrink more effectively before surgery. The main thing they're measuring is something called 'pathological complete response' (pCR). This is a medical term for when no sign of cancer cells can be found in the breast or lymph nodes after the treatment and surgery. Achieving a pCR is often a very good sign that the treatment has been successful. The results of this study could help doctors decide on the best way to use these treatments together in the future.

Key takeaways

This study is for early-stage triple-negative breast cancer.
It tests a new drug, nivolumab, with standard chemotherapy.
The main goal is to see if the cancer disappears completely before surgery.
Your immune system may be boosted to fight the cancer.
The study aims to find better treatments for this specific cancer type.
Participation includes treatment, regular check-ups, and a 3-year follow-up.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The most important requirement is that you have been diagnosed with early-stage triple-negative breast cancer. This means your cancer has specific characteristics that make it 'triple-negative' and that it has not spread widely in your body. Your doctor will be able to confirm if your cancer fits this description.

There might be other health requirements or previous treatment restrictions that your study doctor will discuss with you to make sure the trial is safe and suitable for your specific situation.

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 18 years old or older?
Have you been diagnosed with early-stage triple-negative breast cancer?
Are you able to attend regular appointments and follow the study schedule?
Are you willing to potentially receive novel treatments alongside standard chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment, which involves either nivolumab on its own for a short period before chemotherapy, or nivolumab given at the same time as your standard chemotherapy (paclitaxel and carboplatin). You will have regular appointments and tests to check how you are responding to the treatment and to monitor your general health. This will involve blood tests, scans, and physical examinations before, during, and after your treatment.

After your main treatment phase, there will be a follow-up period to see how you are doing over time. This follow-up will typically last for three years after you finish your main treatment. The study team will explain the exact schedule of visits and tests to you in detail.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. You might benefit from receiving a new treatment that could be more effective than standard care, and you'll be closely monitored by a dedicated medical team. However, the study drug, nivolumab, and the chemotherapy drugs can cause side effects. These can vary from person to person and will be carefully explained to you by the study team. Some risks are unknown as it's a new combination being tested. It's important to remember that joining the study is entirely your decision, and you have the right to withdraw at any time without affecting your future medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer is a type of breast cancer that doesn't have certain features (receptors for oestrogen, progesterone, or HER2 protein) that are often targeted by other treatments. This means doctors need different approaches to treat it effectively.

What is nivolumab?

Nivolumab (OPDIVO) is a type of drug called immunotherapy. It works by boosting your body's own immune system to help it recognise and fight cancer cells.

What does 'pathological complete response' (pCR) mean?

A 'pathological complete response' means that when doctors examine the breast tissue and lymph nodes after surgery, they can't find any remaining cancer cells. This is a very positive outcome from treatment.

Will I still have chemotherapy?

Yes, this study involves giving nivolumab alongside standard chemotherapy drugs, paclitaxel and carboplatin. The study is looking at the best way to combine them.

How long would I need to be involved in the study?

The active treatment phase will be followed by a monitoring period. You'd be involved in the study, including follow-up, for about three years after your main treatment is finished.