Experimental Medicine Neratinib Seems to Offer Some Advantages Over Herceptin When Treating Metastatic HER2-Positive Disease

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While the experimental targeted therapy medicine neratinib plus the chemotherapy Taxol (chemical name: paclitaxel) wasn’t better than Herceptin (chemical name: trastuzumab) plus Taxol as a first treatment for HER2-positive recurrent or metastatic breast cancer in terms of progression-free survival, a study suggests that the neratinib combination was linked to fewer brain metastases and a longer time until any brain metastases happened.

The study was published online on April 14, 2016 by JAMA Oncology. Read the abstract of “Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial.”

HER2-positive breast cancers make too much of the HER2 protein. ERBB2 is another name for HER2. The HER2 protein sits on the surface of cancer cells and receives signals that tell the cancer to grow and spread. About one out of every four breast cancers is HER2-positive. HER2-positive breast cancers tend to be more aggressive and harder to treat than HER2-negative breast cancers.

Herceptin works by attaching to the HER2 protein and blocking it from receiving growth signals. Herceptin, which is given intravenously, is approved by the U.S. Food and Drug Administration to:

  • treat advanced-stage, HER2-positive breast cancers
  • be given to women with earlier stages of HER2-positive disease as adjuvant treatment (treatment after initial treatment, such as surgery) either alone or as part of a regimen with chemotherapy

Neratinib is a type of targeted therapy medicine called an irreversible pan-HER inhibitor. Neratinib fights HER2-positive breast cancer by blocking the cancer cells’ ability to receive growth signals. Neratinib is a pill taken by mouth. Previous preliminary studies have suggested that neratinib may help treat HER2-positive breast cancer.

Progression-free survival is how long a woman lives without the cancer growing.

In this study, the researchers randomly assigned 479 women diagnosed with metastatic or recurrent HER2-positive breast cancer that hadn’t been treated yet to one of two treatments:

  • neratinib plus Taxol (242 women)
  • Herceptin plus Taxol (237 women)

The study was conducted from 2009 to 2014 at 188 centers in 34 countries.

Median progression-free survival was 12.9 months in both groups. This means that half the women in both groups lived longer than 12.9 months without the cancer growing and half the women lived for shorter time periods before the cancer grew. It also means that both treatments were about equally effective.

The researchers reported that women in the neratinib-Taxol group were less likely to have the breast cancer spread to the brain compared to women in the Herceptin-Taxol group. This difference was statistically significant, which means that it was likely because of the difference in treatment and not just due to chance.

Women treated with the neratinib-Taxol combination also had a longer time until breast cancer spread to the brain, if it did spread there, compared to women treated with the Herceptin-Taxol combination. This difference also was statistically significant.

Like almost all cancer treatments, neratinib can cause side effects, some of them serious.

This study found that diarrhea, vomiting, and nausea were common in women treated with neratinib compared to women treated with Herceptin.

While the results of this study are encouraging, the study was small and the follow-up time was relatively short. The researchers recommended that a larger study be done to confirm the results.

If you’ve been diagnosed with metastatic or recurrent HER2-positive breast cancer and are planning your treatment, you may want to ask your doctor about this study. If you’re willing to participate in a clinical trial, you may have the option of being treated with neratinib instead of Herceptin, if it makes sense for your unique situation. Talk to your doctor about clinical trials that might be a good fit for you. You can visit the Breastcancer.org Clinical Trials pages for more information.

And stay tuned to Breastcancer.org’s Research News for the latest information on neratinib.



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