Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

This research is trying out new ways to treat advanced triple-negative breast cancer, where the cancer has spread to other parts of the body. Doctors are investigating several new medicines, like Durvalumab and others, sometimes combined with standard chemotherapy such as paclitaxel. The main aim is to see how safe these new combinations are and if they can help shrink or control the cancer. This is an early-stage study, meaning it's one of the first times these specific combinations are being tested in people. If early results show promise, more patients might be included in the study later on. It’s for women who haven't had previous treatment for their advanced triple-negative breast cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

243

Start

21 Dec 2018

Estimated completion

26 Feb 2027

Triple Negative Breast Neoplasms

What is this study about?

This study is investigating new treatments for a type of breast cancer called metastatic triple-negative breast cancer. 'Metastatic' means the cancer has spread from the breast to other parts of the body. 'Triple-negative' refers to the fact that this cancer doesn't have certain features (receptors for oestrogen, progesterone, or HER2 protein) that other breast cancers might have, which means standard hormone or HER2-targeted therapies won't work.

The researchers are testing several new medications, such as Durvalumab, Capivasertib, Oleclumab, Paclitaxel, Trastuzumab deruxtecan and Datopotamab deruxtecan. These new drugs are often combined with each other, or with paclitaxel (a common chemotherapy drug). The main goal is to find out if these new combinations are safe for patients and if they can effectively fight the cancer. This is a phased study, meaning it starts with a small group of patients to check for safety and early signs of effectiveness. If things look good, more people will be asked to join to gather more information.

Ultimately, the study aims to improve treatment options for people with this specific type of advanced breast cancer. It's an important step in finding better ways to manage the disease, especially for those who haven't yet received treatment for their advanced cancer.

Key takeaways

This study is for women with advanced, triple-negative breast cancer that has spread.
It's testing new drug combinations to see if they are safe and effective.
Participation involves receiving new treatments and regular health checks.
You must not have had previous treatment for your metastatic triple-negative breast cancer.
The goal is to find better treatment options for this specific type of cancer.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you must be a woman aged 18 or over. You need to have triple-negative breast cancer that has spread to other parts of your body (metastatic), and you shouldn't have had any treatment for this advanced stage of the cancer before. Also, doctors need to be able to measure at least one of your cancer spots accurately.

There are specific requirements for some parts of the study. For example, if you're in a group testing Durvalumab and Trastuzumab deruxtecan, your cancer cells need to show a low amount of a protein called HER2. If you're in a group testing Durvalumab and Datopotamab deruxtecan, your cancer needs to have a specific marker called PD-L1.

You cannot join if you've had an organ transplant, have certain autoimmune or inflammatory conditions, or have active infections like hepatitis, HIV, or untreated cancer spread to your brain. You also can't take part if you're pregnant or breastfeeding, have serious heart problems, or are allergic to any of the study medications.

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 a woman aged 18 or older?
Do you have triple-negative breast cancer that has spread?
Have you *not* had any treatment yet for your advanced breast cancer?
Do you have at least one cancer spot that doctors can measure?
Do you have good general health and fitness (as assessed by a doctor)?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments. You would be given the study drugs, either through an IV (a drip in your arm) or as tablets, depending on the specific medication. Doctors and nurses would monitor you closely for any side effects and to see how the treatment is affecting your cancer. This includes blood tests, scans, and physical examinations.

The total duration of your participation would depend on how your cancer responds to the treatment and your overall health. You would continue receiving treatment and being monitored as long as the treatment is beneficial and you are tolerating it well. There will also be follow-up appointments after you stop the treatment to check on your long-term health. The study is designed to assess safety and effectiveness in stages, so the exact appointments and tests might be adjusted as the study progresses.

Potential risks and benefits

It's important to understand that this study involves new treatments, so there's always a chance of side effects that aren't fully known yet. You might experience common side effects associated with cancer treatments, such as fatigue, sickness, or hair loss, and the study drugs could also have specific side effects. The potential benefit is that these new combinations might be more effective than existing treatments for your type of cancer, offering a new treatment option where others are limited. However, there's no guarantee the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (32)

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

Research Site
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Tucson, United States
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Columbia, United States
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Boston, United States
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Boston, United States
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Grand Rapids, United States
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St Louis, United States
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Dallas, United States
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Williamsburg, United States
Research Site
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Kelowna, Canada
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London, Canada
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Greenfield Park, Canada
Research Site
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Montreal, Canada

Common questions

What is 'triple-negative breast cancer'?

It's a type of breast cancer that doesn't have three specific features (receptors for oestrogen, progesterone, or HER2 protein), which means common hormone therapies or HER2-targeted drugs don't work for it.

What does 'metastatic' mean?

It means the cancer has spread from where it started (the breast) to other parts of your body.

Are the study drugs new?

Yes, they are either new drugs or new combinations of existing drugs that haven't been widely used together for this specific condition before.

Will I definitely get one of the new drugs?

Yes, everyone in the study will receive one of the new treatment combinations being tested. There isn't a placebo group in this study.

How long will I be in the study?

You'll stay in the study for as long as the treatment is helping you and you're not having severe side effects. After stopping treatment, you'll have follow-up checks.