THE CAPTURE CLINICAL TRIAL

What Is The Aim Of The Capture Clinical Trial?

Around 70% of all breast cancers are oestrogen receptor positive.

Endocrine or hormone treatments for these cancers have been effective, but when the cancer advances, the treatment is no longer effective. Therefore, other ways of treating these resistant cancers are needed.

The Breast Cancer Trials CAPTURE clinical trial is attempting to help find a new treatment for these patients.

CAPTURE is open to women and men with oestrogen (ER) positive, HER2 negative metastatic breast cancer with a PIK3CA mutation, that has returned after treatment with a CDK4/6 inhibitor such as ribociclib, palbociclib or abemaciclib.

CAPTURE is investigating if treatment with a PI3K inhibitor (alpelisib), in combination with fulvestrant, will improve outcomes for patients with metastatic breast cancer when compared with standard treatment.

Medical Oncologist and Breast Cancer Trials researcher Professor Sarah Jane Dawson, is leading this clinical trial in Australia.

She said the study could potentially offer a new treatment option for a significant portion of ER positive breast cancer patients whose cancer has progressed after standard treatment.

“We know that when patients progress on those therapies, their breast cancer is showing resistance to endocrine therapies, and the mainstay of treatment for patients in that situation is often chemotherapy.”

“We’re comparing patients that are going to be treated with alpelisib and fulvestrant, to a group of patients treated with a standard chemotherapy drug called capecitabine.”

“We’re expecting and hoping to see that patients that are treated with the targeted therapy alpelisib will have improved survival compared to patients that are treated with the standard chemotherapy alone,” said Professor Dawson.

However, this clinical trial is only open to patients who carry a specific genetic mutation called PIK3CA.

“So, the CAPTURE clinical trial is looking at trying to identify a group of patients that harbour this genetic alteration, PIK3CA, and make a new therapeutic option available to them in the form of a drug called alpelisib, which is a very specific inhibitor of the PI3K signalling pathway,” said Professor Dawson.

She said potentially eligible patients will be required to undergo a blood test to see if they are carriers of the PIK3CA mutation.

“A novel aspect of the CAPTURE trial is that we’re assessing that information through a blood test. We’re utilising a technology called circulating tumour DNA.”

“Currently, this test is not routine. So, the CAPTURE clinical trial really involves testing to identify the presence of this alteration and to match that with a targeted therapy that hopefully will lead to improved outcomes for patients with this type of breast cancer.”

Though 140 patients will be enrolled onto this clinical trial, many more will be screened to find those with a PIK3CA mutation.

“Oestrogen receptor positive breast cancer is the most common type of breast cancer,” said Professor Dawson.

“Around 40% of patients with ER positive HER2 negative breast cancer would carry a PIK3CA gene mutation in their breast cancer.”

“It’s a large patient group, and we’re hoping this trial will really offer a new therapeutic alternative for those individuals.”

How Can I Get Involved In The CAPTURE Clinical Trial?

Professor Dawson advises patients who are interested in participating in the CAPTURE clinical trial should discuss their eligibility with their oncologist and/or treatment team.

Alternatively, if you have any further questions about this clinical trial, you can reach out to us at Breast Cancer Trials.

Or, if you would like to help support this important clinical trial, you can donate to our life-saving research here.