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Clinical Trial of the Month: the PATINA Trial

Clinical Trial of the Month: the PATINA Trial

BCNA is working to ensure that women with breast cancer have access to clinical trials that may benefit them. We have been talking for some time about the CDK inhibitors which are a new class of drugs that have been shown in clinical trials to slow down the progress of disease for women with hormone positive HER2-negative metastatic breast cancer. Now there is a new trial called PATINA that is looking at whether the CDKs might also help women with HER2-positive disease.

We asked Associate Professor Elgene Lim, Laboratory Head & Senior Medical Oncologist, from the Garvan Institute and The Kinghorn Cancer Centre to tell us about PATINA.

 What is the PATINA clinical trial?

The PATINA clinical trial will investigate if the addition of the new drug Palbociclib can lengthen the time that cancer can be controlled and improve survival rates for women with hormone positive, HER2-positive metastatic breast cancer.

The trial which will study whether adding Palbociclib to standard treatment with hormone therapy and anti-HER2 therapy (trastuzumab and pertuzumab) following completion of initial chemotherapy, is better than standard therapy alone.

Who might be eligible for the PATINA trial?

Women who have been diagnosed with the first recurrence or a diagnosis of hormone positive, HER2-positive metastatic breast cancer who are currently receiving chemotherapy in combination with anti-HER2 therapy may be suitable for this trial.

What might the benefit be of adding Palbociclib to hormone treatment for women who have hormone receptor positive, HER2-positive breast cancer?

Palbociclib stops cancer cells from growing by blocking the function of enzymes (proteins that help chemical reactions occur in the body) called Cyclin D Kinase 4 and 6 (CDK 4/6). CDK 4/6 are important enzymes that are part of the growth cycle of certain types of breast cancer cells. This class of drugs will be approved for PBS reimbursement in combination with hormone therapy in patients with hormone positive, HER2-negative, metastatic breast cancer on 1 July 2018.

Results from earlier clinical studies indicate that the combination of a CDK4/6 inhibitor with anti-HER2 therapy may prevent the spread of cancer cells. CDK4/6 inhibitors may also re-sensitise resistant HER2 positive breast cancers to anti-HER2 therapies.

The PATINA clinical trial will investigate if the addition of palbociclib to first-line treatment of HER2-positive breast cancer will delay the onset of therapeutic resistance and prolong survival, as well as finding out more about the side effects, safety and effectiveness of the drug combination.

What side effects might women experience?

Palbociclib is generally well tolerated, although it can cause fatigue and low blood counts, particularly white cells.

Who would not be eligible for the trial?

Patients who have progressed while on adjuvant treatment for early breast cancer, and up to 6 months after completion of adjuvant therapy, and patients with poor heart, liver and other organ function.

How can women find out more about this trial and whether it might be right for them?

This is a collaborative trial between academic oncology centres in the US, Spain, Germany and Australia/New Zealand. The study is conducted in Australia and New Zealand by the Breast Cancer Trials group. More information is available on the Breast Cancer Trials group website www.breastcancertrials.org.au.

To find out whether this clinical trial might be suitable for you, talk to your medical oncologist.