Clinical trial seeks to help HER2-positive breast cancer patients

KeepHealthCare.ORG – Clinical trial seeks to help HER2-positive breast cancer patients

Targeted therapies have extended life for HER2-positive breast cancer patients for 20 years, but experts say that when the disease reaches stage 4 it spreads to the brain in more than 30 percent of patients.

Those patients were barred from clinical trials until now.

That new lifeline is the “HER2CLIMB Study.”

Dikla Benzeevi has been fighting metastatic HER2-positive breast cancer for 16 years. She’s tried 14 drugs and seven lines of therapy.

“Therapy seems to work for about one and a half to two years, and then I start having progression or a new metastasis,” she explains.

Dikla was running out of options. Then her doctor, UCLA oncologist Sara Hurvitz, told her about the HER2CLIMB Study.

It uses an experimental drug called tucatinib along with Herceptin and a chemo drug called Xeloda.

“It’s a small molecule that gets into the cancer cell. It targets the inside of the HER2 receptor and stops it from functioning on the inside,” Hurvitz says.

Tucatinib is small enough to cross the blood-brain barrier, which gives hope to women whose cancer has spread to the brain.

“It’s a very unique opportunity for women who have this very high-risk type of metastatic breast cancer to receive a drug that is potentially going to be effective in that type of disease,” Hurvitz explains.

Dikla has been in the trial for 11 months. She doesn’t know if she’s getting tucatinib or a placebo, but tumors in her lungs are staying small.

“At the minimum, I hope that it keeps me stable, it keeps me feeling good, that I can have the kind of life I want to lead and that I can have it for a long time,” she says.

An early phase clinical trial showed that more than 40 percent of women with brain metastases had shrinkage of their brain tumors, giving Dikla reason to hope.

Tucatinib attacks only the HER2 protein, so it’s not as toxic as other therapies.

The Her2CLIMB Study opened in 2015 and is still enrolling patients at 171 trial sites.

Hurvitz doesn’t anticipate getting results back for a couple of years. If they’re good, she hopes this new therapy could be given to early-stage patients, who are at high risk of relapse, to prevent brain metastases.


REPORT: MB #4439

BACKGROUND: HER2 is a growth-promoting protein on the outside of all breast cells. Breast cancer cells with higher than normal levels of HER2 are called HER2-positive. These cancers tend to grow and spread faster than other breast cancers. Women newly diagnosed with invasive breast cancers should be tested for HER2. It’s important to know your “HER2 status” because HER2-positive cancers are much more likely to benefit from treatment with drugs that target the HER2 protein. A biopsy or surgery sample of the cancer is usually tested with either immunohistochemical stains (IHC) or fluorescent in situ hybridization (FISH).

TREATMENT: Approximately 12 percent of women in the United States will develop invasive breast cancer at some point. Anyone, even men, can develop HER2-positive breast cancer, but it’s more likely to affect younger women. HER2-positive represents about 20 percent of all breast cancers. HER2-positive breast cancer is more aggressive and more likely to recur than HER2-negative breast cancer. Recurrence can happen anytime, but it usually takes place within five years of treatment. Treatment plans usually include surgery, chemotherapy, radiation, or targeted treatments. Metastatic breast cancer is not considered curable. Treatment can continue as long as it’s working.

NEW RESEARCH: Sara Hurvitz, MD, Associate Professor of Medicine, Director of Breast Oncology at UCLA and Jonsson Comprehensive Cancer Center talks about the HER2 Climb study. Dr. Hurvitz explained, “The HER2CLIMB study is a clinical trial that is evaluating a new drug called tucatinib. Tucatinib is an oral drug that targets a protein on the tumor cell called HER2. This study is evaluating whether adding tucatinib to standard of care therapy with capecitabine (an oral form of chemotherapy also known as Xeloda) and trastuzumab (an IV form of HER2 targeted therapy also known as Herceptin) will improve outcomes for women with metastatic HER2+ breast cancer.” While some other small molecule inhibiters of HER2 are FDA approved, they can cause significant side effects. Dr. Hurvitz said, “What’s unique about Tucatinib is its really selective for HER2 so it’s not hitting this other receptor. The hope is, and early data suggests, that we’re going to see less toxicity in terms of rash and diarrhea. The grand hope is that it will not only improve our ability to control breast cancer that’s metastatic but also will do so without increasing toxicity.”
(Source: Sara Hurvitz, MD)


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