AuthorisedTherapeutic exploratory (Phase II)Interventional

SAKK 66/22: Intratumoral INT230-6 followed by neoadjuvant immuno-chemotherapy in patients with early triple-negative breast cancer (TNBC). An open-label randomized two-cohort phase 2 clinical trial. INVINCIBLE-4-SAKK

This study, called INVINCIBLE-4-SAKK, is investigating a new treatment approach for early triple-negative breast cancer (TNBC). Patients will receive an injection of a drug called INT230-6 directly into their breast tumour. This is followed by chemotherapy and immunotherapy, which are standard treatments. The main goal is to see if this combination can completely clear the cancer from the breast and lymph nodes before surgery. This might lead to better outcomes for patients. Researchers will also look at how often breast-conserving surgery is possible and monitor for any side effects. This is a Phase 2 study, meaning it's exploring how well the treatment works and its safety.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Swiss Cancer Institute

Enrolment target

Start

23 Apr 2025

Early triple-negative breast cancer (TNBC)

What is this study about?

This clinical trial is designed to investigate a new way of treating early triple-negative breast cancer, a type of breast cancer that can be more challenging to treat. The study is called INVINCIBLE-4-SAKK and involves a specific treatment plan before surgery. Participants will first receive an injection of a new investigational drug called INT230-6 directly into their breast tumour. This is then followed by a combination of chemotherapy and immunotherapy, which are already used to treat breast cancer.

The main purpose of this study is to see if this new treatment combination can completely remove the cancer from the breast and any affected lymph nodes before surgery is performed. This is known as a 'pathological complete response' (pCR) and is a good sign that the treatment has been very effective. Researchers will also be monitoring other aspects, such as how much the tumour shrinks, whether patients can have surgery that saves more of the breast, and if there are any side effects.

By taking part, you would be helping doctors understand if this new approach could improve outcomes for people with early triple-negative breast cancer. The study is in Phase 2, which means researchers are actively exploring how well the treatment works and gathering more information about its safety before it can potentially become a standard treatment option.

Key takeaways

This study is for early triple-negative breast cancer.
It tests a new drug injected into the tumour, plus standard treatments.
The main goal is to see if cancer can be fully cleared before surgery.
It's a Phase 2 study, exploring effectiveness and safety.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

This study is looking for both men and women aged 18 or older. You would be considered if you have been diagnosed with early triple-negative breast cancer.

There might be other health conditions or previous treatments that could mean this study isn't right for you. The medical team will check all your health details carefully to make sure it's safe for you to take part.

It's important to have a detailed discussion with your doctor to understand if you meet all the requirements for this study.

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 triple-negative breast cancer?
Are you able to commit to the study visits and procedures?
Are you open to receiving an injection directly into your breast tumour?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive an injection of the study drug (INT230-6) directly into your breast tumour. After this, you will have a course of standard chemotherapy and immunotherapy treatments. You will have regular appointments for check-ups, scans, and blood tests to monitor how you are responding to the treatment and to keep an eye on your general health. These visits will allow the study doctors to assess the size of your tumour and check for any side effects. The total duration of your participation will include the treatment period, followed by your surgery, and subsequent follow-up appointments. The exact number of visits and the full timeline will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment approach for triple-negative breast cancer that could be more effective than current standard treatments alone. However, as with any medical treatment, there are potential risks and side effects associated with the study drug, chemotherapy, and immunotherapy. These will be thoroughly explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
France

Common questions

What is triple-negative breast cancer?

Triple-negative breast cancer is a type of breast cancer that doesn't have the three most common 'receptors' that can be targeted with specific drugs. This means different treatment approaches are needed.

What is INT230-6?

INT230-6 is an investigational drug being tested in this study. It's given as an injection directly into the breast tumour.

What does 'neoadjuvant' mean?

'Neoadjuvant' means the treatment is given before surgery, with the aim of shrinking the tumour and making surgery more successful or less extensive.

What is a 'pathological complete response'?

A 'pathological complete response' means that when the breast tissue and lymph nodes are examined after surgery, no cancer cells are found. This is a very good sign that the treatment has worked well.

Will I still need surgery if I participate?

Yes, even if the treatment works very well, surgery remains a part of the treatment plan for early triple-negative breast cancer in this study.