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A study suggests that an injectable form of Herceptin (chemical name: trastuzumab) works just as well as and is as safe as the standard intravenous (IV) form of Herceptin to treat HER2-positive, early-stage breast cancer before surgery.

The study was published online by The Lancet on Aug. 9, 2012. Read “Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I—III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial.”

HER2-positive breast cancers have too many copies of the HER2/neu gene, which make too much of the HER2 protein. HER2-positive breast cancers tend to be aggressive, so treatment before surgery may be recommended. Herceptin is a targeted therapy that fights against HER2-positive breast cancers by blocking the cancer cells' ability to receive growth signals.

Herceptin isn’t approved by the U.S. Food and Drug Administration to be used before surgery to treat early-stage breast cancer, but doctors sometimes use Herceptin that way. Doctors call treatments given before surgery “neoadjuvant” treatments.

Right now, Herceptin only can be given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or a port. The first dose of Herceptin takes about 90 minutes. After that, it takes about 30 minutes to get the other doses of Herceptin, which are usually given weekly in a doctor’s office.

In this study, called the HannaH trial, researchers looked at the effectiveness and safety of an injectable (also called “subcutaneous,” which means “under the skin”) form of Herceptin. The injectable form is injected under the skin using a hypodermic needle, much like a vaccine. The injection takes about 5 minutes. The women in the study were taught how to give themselves the Herceptin injection.

The researchers wanted to know if the injectable form of Herceptin works as well as and is as safe as the IV version to treat HER2-positive stage I, II, or III (early-stage) breast cancer before surgery.

The HannaH trial involved 596 women diagnosed with early-stage, HER2-positive breast cancer. Before surgery, all the women got the chemotherapy medicine Taxotere (chemical name: docetaxel) followed by a combination of the chemotherapy medicines fluorouracil, Ellence (chemical name: epirubicin), and Cytoxan (chemical name: cyclophosphamide). The women also got Herceptin while they were getting chemotherapy and for a year after surgery:

  • 299 women got the IV form of Herceptin
  • 297 women got the injectable form of Herceptin

After the chemotherapy was done, the women had surgery to remove the cancer. The researchers recorded how many women had no active cancer cells in the tissue removed during surgery. When there are no cancer cells in the tissue removed, doctors call it a “pathologic complete response.” Some doctors believe a pathologic complete response to treatment before surgery means the cancer is less likely to come back (recurrence).

The two groups of women had similar pathologic complete response rates. The pathologic complete response rates were:

  • 45.4% in women who got injectable Herceptin
  • 40.7% in women who got IV Herceptin

Both groups had about the same number of side effects – having a low white blood cell count was the most common. Women injecting themselves with Herceptin had a slightly higher rate of serious infection (24 women) compared to women getting the IV Herceptin (13 women). Still, the infections weren’t in the area where the women were giving themselves the Herceptin injections.

An injectable form of Herceptin that’s as effective and safe as the standard IV version could be a more convenient option for some women diagnosed with early-stage, HER2-positive breast cancer. The injection takes much less time than the IV version and can be done in a woman’s home, saving her a trip to the doctor’s office.

While the results of the HannaH trial are promising, more research needs to be done before doctors know for sure that injectable Herceptin offers exactly the same benefits as the standard IV version.

If you’ve been diagnosed with early-stage, HER2-positive breast cancer and will have treatment before surgery, 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 injectable Herceptin. Talk to your doctor about clinical trials that might be a good fit for you and your unique situation. Visit the Clinical Trials section for more information.

And stay tuned to’s Research News for the latest information on injectable Herceptin.

Editor’s Note: On Feb. 28, 2019, the U.S. Food and Drug Administration approved an injectable form of Herceptin called Herceptin Hylecta (chemical name: trastuzumab and hyaluronidase-oysk) to treat people diagnosed with HER2-positive breast cancer.

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