Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of the proposed biosimilar PERT-IJS versus EU-Perjeta® along with trastuzumab and chemotherapy (carboplatin and docetaxel) as neoadjuvant treatment in chemotherapy naïve patients with early stage or locally advanced HR negative and HER2 positive breast cancer

This research study is for women with a specific type of breast cancer that's called HER2-positive and hormone receptor-negative. This cancer can be found early or be a bit more advanced locally. The study is comparing a new medication, called PERT-IJS, with a currently approved drug named Perjeta®. Both drugs are given alongside other standard breast cancer treatments (trastuzumab and chemotherapy like carboplatin and docetaxel) before surgery. This type of treatment before surgery is called 'neoadjuvant' therapy. The main goal is to check if PERT-IJS is as effective and safe as Perjeta® for these patients. It's a Phase 3 study, meaning it's a large trial to confirm the benefits and safety of the new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Biocon Biologics UK Limited

Enrolment target

Start

22 Nov 2023

Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-positive Early Stage or Locally Advanced Breast Cancer

What is this study about?

This study is about a new version of a medicine for a specific type of breast cancer. This cancer is known as HER2-positive and hormone receptor-negative. HER2-positive means the cancer cells have too much of a protein called HER2, which helps them grow quickly. Hormone receptor-negative means the cancer doesn't grow in response to hormones like oestrogen or progesterone. This study focuses on cancer that's either in its early stages or has spread a little bit locally, but hasn't spread to distant parts of the body.

The new medicine being tested is called PERT-IJS. It's a 'biosimilar' drug, which means it's designed to be very similar to an existing approved drug, in this case, Perjeta®. Just like generic drugs are similar to brand-name drugs, biosimilars are similar to complex biological medicines. The study wants to see if PERT-IJS works just as well and has a similar safety profile as Perjeta®.

Patients in this study will receive either PERT-IJS or Perjeta®, along with other standard breast cancer treatments. These include trastuzumab (another HER2-targeted drug) and chemotherapy drugs like carboplatin and docetaxel. This combination of treatments will be given before any surgery, which is called 'neoadjuvant' treatment. The main reasons for giving treatment before surgery are to shrink the tumour, making surgery easier, and to help doctors understand how well the cancer responds to the drugs.

Key takeaways

The study is for early-stage or locally advanced HER2-positive, hormone receptor-negative breast cancer.
It's comparing a new drug (PERT-IJS) to an existing one (Perjeta®) as part of pre-surgery treatment.
All participants will also receive trastuzumab and chemotherapy.
The main goal is to check if the new drug is as effective and safe.
Participation involves regular hospital visits for treatment and monitoring.
You must be a female aged 18 or over and not have had prior chemotherapy for this condition.

Who may be eligible?

This study is looking for women who have been diagnosed with a specific kind of breast cancer. This means your cancer must be HER2-positive and hormone receptor-negative. It needs to be either early-stage or locally advanced, meaning it hasn't spread to distant parts of your body. You also must not have had chemotherapy before for this breast cancer.

To join, you need to be at least 18 years old. There's no upper age limit for taking part in this study. The study is specifically for women.

There might be other specific health requirements or conditions that could affect whether you can join, which a doctor or research nurse would discuss with you.

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.

Am I a woman?
Am I 18 years old or older?
Has my breast cancer been confirmed as HER2-positive?
Has my breast cancer been confirmed as hormone receptor-negative?
Is my cancer considered early stage or locally advanced (not spread far)?
Have I NOT had chemotherapy for my breast cancer before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive cycles of treatment over several months before any surgery. This would involve regular visits to the hospital or clinic to receive your medications, which would be given through an infusion (into a vein). During these visits, the research team would closely monitor your health, check for any side effects, and perform various tests like blood tests, scans, and physical examinations to see how you are responding to the treatment.

After your pre-surgery treatment is completed and you have surgery, there would be a follow-up period. This involves continued check-ups and monitoring to keep track of your health and ensure the treatment's long-term effectiveness and safety. The exact number of visits, tests, and the total duration would be explained in detail by the study team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving close medical attention and access to new treatments like PERT-IJS before they are widely available. However, there are also potential risks; the new drug might have side effects that are not yet fully known, or it may not be as effective for everyone. You will be monitored very closely for any side effects. Remember, joining a study is always voluntary, and you have the right to withdraw at any time without explaining why, and this will not affect your usual medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Romania

Common questions

What is HER2-positive breast cancer?

HER2-positive breast cancer means the cancer cells have too much of a protein called HER2, which makes them grow quickly. Targeted treatments like the ones in this study aim to block this protein.

What does 'neoadjuvant treatment' mean?

'Neoadjuvant treatment' means treatments given before surgery. The aim is to shrink the cancer, making surgery easier and sometimes more effective, and to see how the cancer responds to the drugs.

What is a 'biosimilar' drug?

A biosimilar drug is a highly similar, approved version of an existing biological medicine. It's like a generic version, but for complex medications made from living cells. It should work in the same way with similar safety.

Will I know if I'm getting the new drug or the existing one?

In this type of study, patients usually don't know whether they are receiving the new biosimilar (PERT-IJS) or the established drug (Perjeta®). This is called 'blinding' and helps ensure the study results are fair and unbiased.

Will I still have surgery if I join this study?

Yes, this study involves giving treatment before surgery. The aim is to make the tumour smaller and potentially easier to remove. Surgery is still a key part of the treatment plan for most people with this condition.