Active not recruitingPHASE1, PHASE2INTERVENTIONAL

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)

This research, called TACTIVE-U, is a clinical trial exploring a new medicine named vepdegestrant (also known as ARV-471) alongside another medicine called ribociclib. It's for people in the UK with advanced breast cancer that has spread to other parts of the body (metastatic breast cancer). Specifically, it targets breast cancer that is sensitive to hormones (oestrogen receptor positive) and has stopped responding to previous treatments. All participants in this part of the study will take both ARV-471 and ribociclib by mouth once a day. Researchers want to understand if this combination is safe and if it can help stop the cancer from growing. They will also look at any side effects people might experience.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Pfizer

Enrolment target

Start

01 Mar 2023

Estimated completion

30 Dec 2026

Breast Cancer

What is this study about?

This study is called TACTIVE-U and focuses on advanced breast cancer. This means the cancer may have spread to other parts of the body and can't be completely removed by surgery or treated by radiotherapy. The trial is looking at a new medicine, which has a research name of ARV-471 (also known as vepdegestrant). This new medicine will be given together with an existing medicine called ribociclib.

The main aim is to find out if this combination of medicines is safe and if it helps to treat this type of breast cancer. They are specifically interested in breast cancer that is sensitive to hormones (often called oestrogen receptor positive) and has already been treated with other medicines but is no longer responding to them.

By carefully watching how people taking these medicines feel and if their cancer changes, the doctors and researchers want to understand if this new treatment approach could be a useful option for other people with advanced breast cancer in the future. The study is divided into different 'sub-studies', and this particular one is called Sub-Study B.

Key takeaways

This study investigates a new treatment for advanced breast cancer.
It uses a combination of ARV-471 (vepdegestrant) and ribociclib.
It's for hormone-sensitive breast cancer that isn't responding to past treatments.
Participation involves daily oral medication and monthly clinic visits.
The main goals are to check the treatment's safety and effectiveness.
You can stop participating at any time.

Who may be eligible?

To join this study, your breast cancer must be advanced or have spread to other parts of your body. It needs to be the type that is sensitive to hormones (oestrogen receptor positive) and has not responded well to at least one previous treatment, but no more than two. Crucially, you must have tried a specific type of cancer drug called a CDK4/6 inhibitor before, which could have been at any stage of your cancer journey.

You also need to have at least one part of your cancer that can be measured by doctors. Your general health and ability to carry out daily activities should be good, meaning you can look after yourself.

You cannot join if your cancer is causing life-threatening problems right now, if you have certain lung or heart conditions, or if you have specific brain tumours that are causing symptoms. Also, if you have had other types of cancer recently (apart from some skin or cervical cancers), or if your kidney or liver are not working well, you would not be able to take part.

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.

Is my breast cancer advanced or has it spread to other parts of my body?
Is my breast cancer considered 'oestrogen receptor positive' (hormone-sensitive)?
Has my cancer already been treated with a CDK4/6 inhibitor medicine?
Am I generally well, and can I do my daily activities mostly independently?
Do I have any other major uncontrolled health problems like severe heart or lung issues?
Do I have brain tumours that are causing symptoms, or have they been recently diagnosed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take two medicines by mouth, once a day, at home. These are ARV-471 and ribociclib. You'll continue taking them for as long as the treatment is helping your cancer and you are not experiencing severe side effects. You will need to attend appointments at the study clinic about once every four weeks. During these visits, the medical team will check how you are feeling, look for any side effects, and monitor your cancer's response to the treatment. They will also take blood tests and perform other checks to make sure the medicines are safe for you.

Potential risks and benefits

Participating in a clinical trial means you'll receive careful medical attention and could gain access to a new treatment before it's widely available. This treatment might help slow down your cancer or improve how you feel, although there's no guarantee it will work for everyone, and it might not be better than standard treatments. There are also potential risks involved, as all medicines can cause side effects. These can range from mild to serious, and the study team will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

Stanford Women's Cancer Center
Verified postcode
Palo Alto, United States
UCSF Medical Center at Mission Bay
Verified postcode
San Francisco, United States
Moffitt Cancer Center - International Plaza
Verified postcode
Tampa, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Verified postcode
Tampa, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Moffitt McKinley Hospital
Verified postcode
Tampa, United States
Siteman Cancer Center - WUPI
Verified postcode
Shiloh, United States
Brigham and Women's Hospital
Verified postcode
Boston, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Dana-Farber Cancer Institute - Chestnut Hill
Verified postcode
Newton, United States
Siteman Cancer Center - St Peters
Verified postcode
City of Saint Peters, United States
Siteman Cancer Center - West County
Verified postcode
Creve Coeur, United States

Common questions

What type of breast cancer is this study for?

This study is for advanced or metastatic breast cancer that is oestrogen receptor positive (hormone-sensitive) and has stopped responding to previous treatments.

What medicines will I be taking?

You will be taking two medicines: ARV-471 (also known as vepdegestrant) and ribociclib. Both are taken by mouth once a day.

How long will I be in the study?

You will continue taking the medicines and having clinic visits for as long as the treatment is helping your cancer and you are not experiencing severe side effects.

Will I have regular check-ups?

Yes, you will have regular visits at the study clinic, typically about every four weeks, to monitor your health and the treatment's effects.

Can I leave the study if I change my mind?

Absolutely. You can choose to leave the study at any time, for any reason, and this will not affect your ongoing medical care.