Active not recruitingPHASE3INTERVENTIONAL

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

This research study is for people with locally advanced or metastatic triple-negative breast cancer (TNBC). This is a type of breast cancer that has either spread to other parts of the body or is advanced and cannot be removed by surgery. The study is comparing a new treatment combination: a drug called Capivasertib taken alongside the chemotherapy drug Paclitaxel, versus Paclitaxel alone (with a dummy pill instead of Capivasertib). The main goal is to find out if the Capivasertib and Paclitaxel combination is more effective at treating the cancer and if it's safe to use. This kind of study helps doctors understand if new treatments can improve outcomes for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

923

Start

25 Jun 2019

Estimated completion

16 Mar 2026

Triple Negative Breast Neoplasms

What is this study about?

This study is looking into new ways to treat a specific kind of breast cancer called triple-negative breast cancer (TNBC). TNBC is often more aggressive and can be harder to treat because it doesn't respond to some common breast cancer therapies. This study focuses on TNBC that is either locally advanced (meaning it has grown significantly in the area and can't be surgically removed) or metastatic (meaning it has spread from the breast to other parts of the body). It's a 'first-line' treatment study, which means it's testing a new approach for people who haven't had other treatments for their advanced or spread cancer yet.

The study involves two main treatment groups. One group will receive a new drug called Capivasertib along with a chemotherapy drug called Paclitaxel. Paclitaxel is a commonly used chemotherapy for breast cancer. The other group will receive Paclitaxel plus a 'placebo' – which looks like Capivasertib but contains no active drug. This allows the research team to fairly compare the effects of adding Capivasertib to the standard chemotherapy.

The main aim of this research is to see if adding Capivasertib to Paclitaxel works better than Paclitaxel alone in slowing down or stopping the cancer's growth. Researchers will also be carefully monitoring any side effects to understand how safe the new combination is. The information gathered from studies like this is vital for developing new and more effective treatments for breast cancer patients in the future.

Key takeaways

This study is testing a new combination treatment for advanced or spread triple-negative breast cancer.
It combines a new experimental drug, Capivasertib, with standard chemotherapy (Paclitaxel).
The goal is to see if this new combination is more effective than standard treatment alone.
Participants will be randomly assigned to receive either Capivasertib or a dummy pill alongside their chemotherapy.
Regular hospital visits, tests, and scans will be part of the study process.
It's important to discuss all potential risks and benefits with your doctor before deciding.

Who may be eligible?

To be eligible for this study, you would need to have triple-negative breast cancer that has been confirmed by a doctor, and your cancer needs to be advanced locally (meaning it can't be taken out with surgery) or have spread to other parts of your body. You should also generally be well enough to take part, as assessed by a doctor, and be aged 18 or older.

There are certain reasons why you might not be able to join. For example, if you've already had chemotherapy for breast cancer in the last six months, or special types of chemotherapy called taxanes in the last year, you might not be able to take part. Also, if you've previously received treatment for your advanced or spread cancer, this study might not be suitable for you.

Additionally, if you've ever had specific types of drugs called AKT, PI3K, or mTOR inhibitors, or if you've taken part in a previous study with Capivasertib, you wouldn't be able to join. Your doctor will carefully review all your medical history to make sure the study is right 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.

Have I been diagnosed with triple-negative breast cancer?
Has my cancer spread or is it locally advanced and cannot be surgically removed?
Am I aged 18 or older?
Have I had no chemotherapy for cancer in the last 6 months (or special types of chemotherapy in the last 12 months)?
Have I not had treatment for my advanced or spread cancer before?
Have I never taken drugs like AKT, PI3K, or mTOR inhibitors?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group gets Capivasertib plus Paclitaxel chemotherapy, and the other gets a dummy pill (placebo) plus Paclitaxel chemotherapy. You wouldn't know which group you're in, and neither would your study doctor. You would take the study medication (Capivasertib or placebo) by mouth and receive Paclitaxel as an infusion.

You would have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits might be frequent at the beginning and then become less often over time. This helps the study team keep a close eye on your progress and any side effects. The total length of your participation would depend on how your cancer responds to treatment and how you are feeling, but it would involve continuous treatment and follow-up until the treatment is no longer beneficial or you decide to stop.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment combination that could be more effective for your cancer than standard treatment. However, there's no guarantee that the new drug will work for you, and it's also possible that the Capivasertib and Paclitaxel combination could lead to side effects. These side effects could be different or more severe than those from Paclitaxel alone. Your study doctor will discuss all known and potential risks with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (260)

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

Research Site
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Whittier, United States
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Whittier, United States
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Fort Myers, United States
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Miami, United States
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St. Petersburg, United States
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Tampa, United States
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Chicago, United States
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Westwood, United States
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Silver Spring, United States
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Detroit, United States
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Nyack, United States
Research Site
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Cincinnati, United States

Common questions

What is Triple-Negative Breast Cancer (TNBC)?

TNBC is a type of breast cancer that doesn't have the receptors (special proteins) that are often targeted by some common breast cancer treatments. This means it needs different treatment approaches.

What is Paclitaxel?

Paclitaxel is a standard chemotherapy drug often used to treat various types of cancer, including breast cancer. It works by stopping cancer cells from growing and dividing.

What is Capivasertib?

Capivasertib is an experimental drug that works in a different way to chemotherapy. It aims to block pathways inside cancer cells that help them grow and survive.

Why is there a dummy pill (placebo) in the study?

The dummy pill helps researchers fairly compare the new drug combination with just the standard chemotherapy. This way, they can clearly see if adding Capivasertib makes a real difference.

How long will I be in the study if I join?

The length of your participation will depend on how your cancer responds to the treatment and your overall health. It could involve ongoing treatment and regular check-ups for an extended period.