AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

PHASE IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF ZANIDATAMAB IN COMBINATION WITH TUCATINIB AND CHEMOTHERAPY (CAPECITABINE OR ERIBULIN MESYLATE) IN HER2-POSITIVE ADVANCED BREAST CANCER (The JAZMINE Study)

The JAZMINE study is looking into new ways to treat advanced HER2-positive breast cancer. Researchers are testing a new drug called zanidatamab alongside other approved cancer medicines, tucatinib and chemotherapy (either capecitabine or eribulin). The main goals are to find the safest dose of these drug combinations and see how well they work to stop the cancer from growing. This study is split into two parts: Phase 1 aims to find the best dose, and Phase 2 will then use that dose to see if the treatment helps people live longer without their cancer getting worse. It’s for adults aged 18 and over, and both men and women can take part.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

129

Start

05 May 2026

HER2 positive advanced breast cancer

What is this study about?

This clinical trial, known as JAZMINE, is investigating a new treatment approach for a specific type of advanced breast cancer called HER2-positive breast cancer. When breast cancer is HER2-positive, it means the cancer cells have too much of a protein called HER2, which helps them grow quickly. Advanced breast cancer is cancer that has spread beyond the breast to other parts of the body.

The study combines a new investigational drug called zanidatamab with two established cancer treatments: tucatinib and chemotherapy (either capecitabine or eribulin). Researchers want to understand if this new combination is safe and how well it works together to slow down or stop the cancer from getting worse. This is an important step in finding better treatments for people living with this type of cancer.

The trial is divided into two main stages. The first stage (Phase 1) is focused on carefully finding the right dose of zanidatamab to use when given with tucatinib and chemotherapy. This is done by starting with small doses and slowly increasing them while closely monitoring for any side effects. Once the safest and most effective dose is found, the second stage (Phase 2) will then use this dose in more people to see its full effect on the cancer, particularly how long people live without their cancer growing.

Key takeaways

The JAZMINE study aims to find a new treatment for advanced HER2-positive breast cancer.
It combines a new drug (zanidatamab) with existing treatments (tucatinib and certain chemotherapies).
The first part of the study focuses on finding the safest dose for this new combination.
The second part will then look at how well this treatment stops cancer growth.
This study is for adults over 18 with this specific type of advanced breast cancer.
Participation involves regular clinic visits for medication, tests, and monitoring.

Who may be eligible?

This study is open to adults who are 18 years old or older. Both men and women can take part if they meet the other specific requirements for the study.

To be considered, you must have advanced HER2-positive breast cancer. This means your breast cancer has spread to other parts of your body, and your cancer cells have high levels of the HER2 protein.

The study team will review your full medical history and results from specific tests to make sure that taking part in this study is safe and appropriate for you. There will be other detailed medical conditions that you'll need to meet, which your doctor will explain.

Quick self-check

Are you 18 years old or older?
Do you have advanced HER2-positive breast cancer?
Have you discussed this trial with your doctor?
Are you able to attend regular clinic appointments and follow study instructions?
Are you willing to potentially receive a new, investigational treatment?

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

What does participation involve?

If you decide to take part in the JAZMINE study, you will receive the study medications which include zanidatamab, tucatinib, and either capecitabine or eribulin, along with other supportive medications like pain relief or anti-sickness drugs as needed. Each study cycle may involve receiving these medications through different methods, such as pills you take at home or injections/infusions given at a clinic.

You will have regular visits to the clinic for medical check-ups, blood tests, and scans (like X-rays or CT scans) to monitor your health and how well the treatment is working. The exact schedule of visits and assessments will vary but will be explained in detail by the study team. You will also have follow-up appointments after your treatment period to see how you are doing long-term.

The total duration of your participation will depend on how you respond to the treatment and the study plan, but detailed information will be provided by the study team.

Potential risks and benefits

Taking part in a clinical trial like JAZMINE may offer potential benefits, such as access to a new treatment combination that is not yet widely available. It could provide a new option if standard treatments haven't worked well for you. However, there are also potential risks involved. The study drugs may cause side effects, some of which could be serious. The study team will closely monitor you for any side effects and manage them as best they can. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is HER2-positive advanced breast cancer?

This is a type of breast cancer where the cancer cells have a lot of a protein called HER2. This makes the cancer grow faster and means it has spread to other parts of the body.

What are they testing in this study?

They are testing a new drug called zanidatamab in combination with existing cancer medicines, tucatinib and chemotherapy (either capecitabine or eribulin), to see if this mix is safe and helps treat the cancer.

What does 'Phase 1' and 'Phase 2' mean?

Phase 1 is the first stage where they find the safest dose of the new treatment. Phase 2 then checks how effective that safe dose is in treating more people with the cancer.

Will I get the new drug?

If you join the study and meet all the requirements, you will receive the experimental drug zanidatamab along with the other prescribed treatments. This is not a placebo-controlled study for the main treatment.

How long will I be in the study?

The length of time you participate will depend on how your cancer responds to the treatment and the specific study plan. Your doctors will discuss this with you before you join.