Active not recruitingPHASE3INTERVENTIONAL

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

This clinical trial is investigating a medication called Olaparib for individuals in the UK diagnosed with a particular type of HER2-negative breast cancer that has a BRCA gene mutation. After completing usual treatments like surgery and chemotherapy, participants will either receive Olaparib or a dummy pill (placebo) for up to a year. The main goal is to determine if Olaparib can reduce the chance of the cancer returning. Researchers will carefully monitor participants over many years to check for cancer recurrence and track their general health. The study hopes to find new ways to improve long-term outcomes for those living with this type of breast cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,837

Start

22 Apr 2014

Estimated completion

28 May 2029

Breast Cancer

What is this study about?

This study is looking into a medicine called Olaparib for a specific group of people with breast cancer. We know that some breast cancers are linked to changes in certain genes, called BRCA1 or BRCA2. These changes can increase the risk of developing breast cancer and how it behaves. If you have been diagnosed with HER2-negative breast cancer and have one of these BRCA gene changes, this trial might be relevant to you.

The main idea behind this study is to see if giving Olaparib after standard treatments (like surgery and chemotherapy) can help stop breast cancer from coming back. Olaparib is a type of drug that works by targeting faulty ways cancer cells repair themselves, particularly in cancers with BRCA mutations. By giving it after initial treatments, researchers hope to catch any remaining cancer cells that might otherwise lead to a recurrence.

Participants in the study will be randomly assigned to receive either Olaparib or a placebo (a dummy pill that looks like the real drug but contains no active medicine). This is a common way to test new treatments fairly, ensuring that any differences seen are truly due to the study drug. Everyone will be closely monitored for many years to understand the long-term effects and if the treatment helps prevent the cancer from returning.

Key takeaways

Tests Olaparib to prevent breast cancer recurrence.
For HER2-negative breast cancer with BRCA gene mutations.
Participants receive Olaparib or a placebo for up to a year.
Long-term monitoring for cancer recurrence and general health.
Aims to improve outcomes for this specific breast cancer type.

Who may be eligible?

To join this study, you would need to have been diagnosed with a specific type of breast cancer called 'non-metastatic primary invasive adenocarcinoma'. This means the cancer hasn't spread to distant parts of your body. Your cancer would also need to be either 'triple negative' (meaning it doesn't have receptors for oestrogen, progesterone, or HER2) or HER2-negative but positive for oestrogen and/or progesterone receptors.

You also need to have a confirmed change in your BRCA1 or BRCA2 gene that is thought to be harmful. You must have completed your breast surgery and any underarm lymph node surgery, as well as at least six rounds of chemotherapy. Your general health and ability to carry out daily activities, as measured by a scale called ECOG, should be good.

There are also reasons why you might not be able to join. For example, if you've already had a similar type of drug called a PARP inhibitor, or if you have certain other serious medical conditions or are taking particular medications that could interfere with the study drug. The research team will carefully check all these details with 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 you been diagnosed with HER2-negative breast cancer?
Do you have a harmful change in your BRCA1 or BRCA2 gene?
Have you completed breast surgery and at least 6 cycles of chemotherapy?
Are you generally feeling well and able to manage daily activities?
Have you never taken a PARP inhibitor drug before?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to receive either Olaparib or a matching dummy pill (placebo). You will take this study medicine for up to 12 months. During the first month, you'll have safety checks every two weeks. For the next five months, these checks will be every four weeks, and then every three months for the remaining six months of treatment. There will also be a follow-up safety check about a month after you stop taking the study medicine.

Throughout the study, for up to 10 years, you'll have regular hospital visits to check for any signs of the cancer returning. These visits will include talking about your health, physical examinations, and regular mammograms or breast MRI scans. In the early years, these checks will be more frequent (every three to six months), becoming annual later on. After 10 years, the researchers will continue to follow your survival status for many more years, potentially up to 10 years after the last person joins the study.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment (Olaparib) that is not yet widely available, which may reduce the chance of your cancer returning. However, there's no guarantee the treatment will work for you, and it might not be more effective than the placebo. Like all medicines, Olaparib can cause side effects, and some common ones might include feeling tired, nausea, or changes in blood counts, which will be carefully monitored. There are also risks associated with receiving a placebo and not an active drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (698)

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

Research Site
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Anchorage, United States
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Anchorage, United States
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Gilbert, United States
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Fort Smith, United States
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Baldwin Park, United States
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Berkeley, United States
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Duarte, United States
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Fontana, United States
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Fresno, United States
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Greenbrae, United States
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Los Angeles, United States
Research Site
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Los Angeles, United States

Common questions

What is HER2 negative breast cancer?

HER2 negative breast cancer means the cancer cells don't have too much of a protein called HER2. This affects which treatments might work best. This study is for this specific type of breast cancer.

What is a BRCA gene mutation?

BRCA1 and BRCA2 are genes that normally help repair damaged DNA. A 'mutation' or change in these genes can mean they don't work properly, increasing the risk of certain cancers, including breast cancer.

What is Olaparib and how does it work?

Olaparib is a targeted drug known as a PARP inhibitor. It works by blocking a repair pathway in cancer cells, particularly effective in those with BRCA gene changes, making it harder for these cells to survive.

Why is there a placebo group in the study?

Using a placebo helps researchers fairly compare the new drug (Olaparib) to no active treatment. This is important to understand if any benefits seen are truly due to the drug and not other factors.

How long will I be followed up in this study?

You will have regular clinical check-ups for up to 10 years after joining the study. After that, your survival will be tracked for an even longer period.