RecruitingPHASE2INTERVENTIONAL

PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative Breast Cancer

The PHOENIX trial is investigating new approaches for women with triple negative breast cancer. This is a type of breast cancer that doesn't have certain hormone receptors or too much of a protein called HER2. Some patients get chemotherapy before surgery, and this study is for those whose cancer didn't completely disappear after that initial treatment. We're giving these patients new medicines for a short time before their operation. These medicines include AZD6738, Olaparib, and Durvalumab, which work in different ways to fight cancer. The main goal is to see if these short treatments can make a difference to the remaining cancer tissue before it's removed during surgery, helping us understand how they might work in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

119

Start

15 Oct 2019

Estimated completion

01 Jun 2029

Breast Neoplasm Triple Negative Breast Cancer (TNBC)HRD

What is this study about?

The PHOENIX trial is a research study looking into new ways to treat triple negative breast cancer. This type of breast cancer is known to be more challenging to treat because it doesn't respond to hormone therapies or treatments that target the HER2 protein. Many patients with triple negative breast cancer receive chemotherapy before their surgery to try and shrink the tumour. However, for some, the cancer doesn't completely go away.

This study is for those patients whose cancer is still present after their initial chemotherapy but before their surgery. We are testing giving new medicines for a short period – a 'window of opportunity' – between their chemotherapy and surgery. These medicines include AZD6738, Olaparib, and Durvalumab. They work in different ways: some target the cancer's ability to repair its DNA, while others help the body's immune system fight the cancer.

The main aim is to see if these short treatments can start to change the cancer tissue in helpful ways before it's removed. By studying the cancer cells before and after this short treatment, researchers hope to learn more about how these drugs work and whether they could be useful in future treatments for triple negative breast cancer. This information could eventually lead to better care for patients. Please note that some parts of this trial (Cohorts A-D) are no longer enrolling new patients.

Key takeaways

Targets triple negative breast cancer that hasn't fully responded to initial chemo.
Tests new medicines for a short time before surgery.
Aims to understand how these new drugs affect cancer cells.
May help develop better treatments for future patients.
Involves biopsies and short-term medication before surgery.
You can withdraw at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a diagnosis of triple negative breast cancer. This means your cancer has been checked and found not to have certain hormone receptors or too much of the HER2 protein. You must have already had at least six cycles of chemotherapy for your breast cancer which was given before your planned surgery.

It's important that your doctors can clearly see your tumour on scans, as the study involves taking tissue samples (biopsies) before and after the short treatment. You should also be fit enough for surgery and able to manage two weeks of study treatment before your operation. You will also need to be well enough to have two biopsies taken around the time of the short treatment section of the trial.

Finally, your doctors will need to confirm the cancer hasn't spread to other parts of your body beyond the breast and nearby lymph nodes, if this is part of your usual care. Your general health, as assessed by a common scoring system (ECOG performance status 0-1), also needs to be good.

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 18 years old or older?
Do you have triple negative breast cancer?
Have you already had chemotherapy before your surgery?
Are you generally well enough for surgery and a short course of study treatment?
Is your cancer visible on scans for doctors to take samples?

Answer every question to see your result.

What does participation involve?

If you join the PHOENIX study, you would receive one of the study medicines for a short period – about two weeks – right before your planned breast cancer surgery. This part is called the 'window of opportunity'. Before you start this short treatment, you'll have an initial biopsy (a small tissue sample taken from the tumour) and another biopsy at the end of the two-week treatment period. After your regular surgery, the doctors will continue to follow your health and treatment for some time, which may involve further checks. The specific medicines you receive will depend on certain characteristics of your tumour, but all involve taking medication for that brief period before surgery. The total duration of follow-up after surgery can vary but is generally for several years to track your progress.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but the information we gather could help future patients with triple negative breast cancer. Like all medications, the study drugs have potential side effects, and your medical team will discuss these with you in detail. There are also risks associated with the biopsies, such as bruising or infection. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (6)

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

Royal Bournemouth Hospital
Verified postcode
Bournemouth, United Kingdom· Not yet recruiting
King's College Hospital
Verified postcode
London, United Kingdom· Recruiting
Christie Hospital NHS Trust
Verified postcode
Manchester, United Kingdom· Not yet recruiting
Velindre Cancer Center at Velinde Hospital
Verified postcode
Cardiff, United Kingdom· Recruiting
Guy's and St Thomas' Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Weston Park Hospital
Verified postcode
Sheffield, United Kingdom· Not yet recruiting

Common questions

What is 'triple negative breast cancer'?

It's a type of breast cancer that doesn't have three common markers: oestrogen receptors, progesterone receptors, and high levels of HER2 protein. This means standard hormone therapy or HER2-targeted drugs don't work for it.

What does 'neoadjuvant chemotherapy' mean?

This is chemotherapy given before surgery. It's often used to shrink larger tumours so they are easier to remove.

What is a 'window of opportunity' study?

This means giving a new treatment for a short time, usually days or weeks, right before a planned surgery. It allows researchers to see how the new treatment affects the tumour quickly.

Will I know which medicine I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know which study medicine you are receiving.

What are the new medicines being tested?

They include AZD6738, Olaparib, and Durvalumab. These are types of drugs that either help damage cancer cell DNA or boost your immune system to fight the cancer.

How to find out more

Christophe Verstegen

phoenix-icrctsu@icr.ac.uk 0203 437 6886 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.