Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Multicenter, Open-label, Single arm, Phase II Clinical Trial to Improve Sacituzumab Govitecan Tolerance in Patients with Metastatic Triple-Negative or Luminal Breast Cancer. – The PRIMED Study –

The PRIMED study is a clinical trial for people with advanced triple-negative or HR+/HER2- breast cancer. It's investigating how to make a treatment called Trodelvy more manageable by reducing common side effects. Specifically, the study is looking at ways to lessen severe diarrhoea and a serious drop in white blood cells (neutropenia) that can happen with this medication. Participants will receive Trodelvy along with other medicines designed to help prevent these side effects. Researchers will closely monitor how often these side effects occur and how severe they are. The aim is to find better ways for patients to receive this important treatment with fewer difficulties, ultimately improving their experience and ability to continue treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

Start

20 Jun 2024

Advanced triple-negative breast cancer (TNBC)Advanced HR[+]/HER2[–] breast cancer.

What is this study about?

The PRIMED study is a medical research project looking into a treatment called Trodelvy (sacituzumab govitecan) for certain types of advanced breast cancer. This treatment is used for breast cancer that has spread to other parts of the body (metastatic) and falls into two categories: triple-negative breast cancer or HR+/HER2- breast cancer. These can be aggressive forms of the disease.

Trodelvy is an important medication, but like many strong cancer treatments, it can have side effects. Two common and sometimes serious side effects are severe diarrhoea and a significant drop in a type of white blood cell called neutrophils (which help fight infection). This study aims to find better ways to manage these side effects so that patients can continue their treatment more comfortably and effectively. Researchers are exploring if giving other medications alongside Trodelvy can help reduce these issues.

By carefully monitoring patients, the study hopes to learn how to make Trodelvy easier to tolerate, allowing more people to benefit from it. They'll be looking at how often these side effects happen, how severe they are, and if the added medications help. This kind of research is crucial for improving cancer care and making treatments more patient-friendly in the future.

Key takeaways

This study is testing ways to reduce side effects of a breast cancer drug called Trodelvy.
It's for people with advanced triple-negative or HR+/HER2- breast cancer.
The main focus is on reducing severe diarrhoea and low white blood cell counts.
Participants will receive Trodelvy along with other medicines to help manage side effects.
Doctors will check your health closely to see how you respond to the treatment.

Who may be eligible?

To be part of the PRIMED study, you would generally need to be an adult, aged 18 or over. This study is open to both men and women.

Crucially, you would need to have specific types of advanced breast cancer: either triple-negative breast cancer (TNBC) that has spread, or hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer that has also spread. The study team will check your medical records to confirm your cancer type and stage.

There might be other health requirements too, which the study doctors would review. These often include checks to make sure you're well enough to take part and that the treatment would be safe for you. It's always best to discuss your full medical history with the study team to see if you meet all the criteria.

Quick self-check

Are you 18 years old or older?
Do you have advanced triple-negative breast cancer (metastatic)?
Do you have advanced HR+/HER2- breast cancer (metastatic)?
Are you able to attend regular hospital/clinic appointments?
Are you willing to take study medications as instructed?

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

What does participation involve?

If you join the PRIMED study, you would primarily be receiving the breast cancer treatment Trodelvy. Alongside this, you might be given other medications, such as Accofil, Neupogen, Zarzio, or Loperamide tablets, which are designed to prevent or manage potential side effects like low white blood cell counts and diarrhoea. These will likely be given through injections or infusions, or as tablets.

Your participation would involve regular visits to the hospital or clinic. During these visits, the study team would closely monitor your health. This would include checking for any side effects, especially diarrhoea and your white blood cell levels, using standard medical guidelines. They will also take blood samples and possibly stool samples to see how your body is responding to the treatment and to investigate changes in your system. They'll also check your tumour size over time.

The overall duration of your participation in the study would depend on how your treatment progresses and how well you tolerate it. There would be a planned treatment schedule, and follow-up appointments to track your long-term health. You'd have a team looking after you and would be able to ask questions at any point.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is receiving Trodelvy, an important medicine for advanced breast cancer, with extra support designed to reduce common uncomfortable or serious side effects like severe diarrhoea and low white blood cell counts. This might make the treatment more manageable for you. However, there's no guarantee the treatment will work for everyone, or that all side effects will be prevented. Potential risks include those associated with Trodelvy itself, and the other medications used to manage side effects, such as allergic reactions or other side effects. You will be closely monitored for any adverse reactions. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

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 other breast cancers might have (estrogen, progesterone, and HER2). This means it's treated differently from other types.

What does HR+/HER2- breast cancer mean?

This means the breast cancer cells have hormone receptors (HR+, like estrogen or progesterone) but do not have too much of the HER2 protein (HER2-). This type of cancer can often be treated with hormone therapy, but if it's advanced, other treatments like Trodelvy might be used.

What are 'side effects' of cancer treatment?

Side effects are unwanted reactions that can happen as a result of medicines. For cancer treatments, common side effects can include feeling tired, sickness, hair loss, and problems like diarrhoea or changes in blood cell counts.

What is neutropenia?

Neutropenia is when you have a lower-than-normal number of neutrophils, which are a type of white blood cell. These cells are very important for fighting off infections, so having low levels can make you more prone to getting sick.

Will I still get my usual cancer care if I join this study?

Yes, you will continue to receive good medical care from the study team. Usually, the study treatment becomes part of your overall care plan, and you will be closely looked after throughout.