Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA

This research study, called HARMONIA, is for people with advanced breast cancer that is hormone receptor-positive and HER2-negative or HER2-enriched. It's comparing two established cancer drugs, Kisqali (ribociclib) and IBRANCE (palbociclib), to see which one works better at keeping the cancer under control. Researchers want to understand if one medicine stops the cancer from growing for longer. They will also look at how patients feel, their quality of life, and any side effects. The goal is to improve treatment options for this type of breast cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Solti Group

Enrolment target

316

Start

04 Sep 2024

Patients with advanced hormone receptor-positive/HER2- negative/HER2-Enriched breast cancer

What is this study about?

This study, named HARMONIA, is looking at advanced breast cancer. This type of cancer is called 'hormone receptor-positive' because its growth is often encouraged by hormones. It's also 'HER2-negative' or 'HER2-enriched', which refers to a specific protein on the cancer cells. Researchers want to compare two common medicines: Kisqali (ribociclib) and IBRANCE (palbociclib). Both are given alongside other hormone-blocking treatments.

The main aim is to find out if one of these medicines is more effective at stopping the cancer from growing or spreading. This is called 'progression-free survival'. The study will also look at how long people live, if their tumours shrink, and overall how they feel. They will also collect information about any side effects to understand how safe and well-tolerated the treatments are.

This is a 'Phase III' study, which means it's a large, important trial that compares new treatments or compares existing treatments to find the best option. The information gathered from this study will help doctors decide the best way to treat people with this type of advanced breast cancer in the future.

Key takeaways

Compares two exiting cancer drugs, Kisqali and IBRANCE.
For advanced hormone receptor-positive, HER2-negative or HER2-enriched breast cancer.
Aims to find out which drug is better at stopping cancer growth.
Also looks at side effects, quality of life, and overall survival.
Participation involves regular hospital visits, tests, and taking study medication.
This is a large, important Phase III study.

Who may be eligible?

To be able to join this study, you would need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

You must have advanced breast cancer that has been identified as being 'hormone receptor-positive' and either 'HER2-negative' or 'HER2-enriched'. Your doctor will be able to confirm if your cancer fits these descriptions based on tests already done.

There will be other medical checks and criteria that your study doctor will discuss with you to make sure the study treatment is suitable and safe for 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.

Are you 18 years old or older?
Do you have advanced breast cancer?
Has your breast cancer been tested and confirmed as 'hormone receptor-positive'?
Has your breast cancer been tested and confirmed as 'HER2-negative' or 'HER2-enriched'?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to receive either Kisqali or IBRANCE, along with your usual hormone therapy. You would take the medication as prescribed, typically as tablets or capsules. You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits might be quite frequent at first and then less often over time.

Throughout the study, you'll be asked about your general well-being and any side effects you might be experiencing. The overall duration you'd be involved in the study would depend on how your cancer responds to the treatment and your general health, but it could last for several years.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of closer medical monitoring and access to a cancer treatment that might be very effective for your condition. However, there are also potential risks; you might experience side effects from the study medication, which your doctors will discuss with you. The treatment may also not work for you, or it might not be better than standard care. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

—
Unverified
Spain
—
Unverified
Portugal

Common questions

What does 'advanced' breast cancer mean?

Advanced breast cancer means the cancer has spread beyond the breast and nearby lymph nodes to other parts of the body.

What does 'hormone receptor-positive' mean?

This means your cancer cells have receptors that attach to hormones, like oestrogen. These hormones can encourage the cancer to grow, and treatments often aim to block this.

What are Kisqali and IBRANCE?

These are both medicines called CDK4/6 inhibitors. They work by blocking certain proteins in cancer cells, which can slow down their growth and division.

Will I know which medicine I'm getting?

Yes, this is an 'open-label' study, which means both you and your study team will know which of the two medicines you are receiving.

Will I have to pay to be in the study?

No, treatments and study-related care are typically provided free of charge in clinical trials. Travel expenses may sometimes be covered, but you should check this with the study staff.