FDA Approves Trastuzumab Shots for Certain HER2-Positive Breast Cancers

Unlike traditional IV trastuzumab (Herceptin), the combination of trastuzumab and hyaluronidase-oyst (Herceptin Hylecta) can be injected under the skin, making treatments quicker
Breast Cancer News
July 12, 2019
Kristine Conner, for LBBC
Reviewed By: 
Shanu Modi, MD

In February 2019, the U.S. Food and Drug Administrationinfo-icon approved the combination of trastuzumabinfo-icon, a HER2-targeting anticancer medicineinfo-icon, and hyaluronidase-oyst, a medicine that helps your body absorb the trastuzumab, for the treatment of certain early-stageinfo-icon and metastaticinfo-icon HER2-positive breast cancers.

Trastuzumab and hyaluronidase-oyst can be injected under the skin, as a shot, in 2 to 5 minutes. Traditional trastuzumab infusions, given by veininfo-icon, can take 30 to 90 minutes.  


HER2-positive breast cancer develops when cells have too many copies of a proteininfo-icon called HER2. About 20 percent of breast cancers are HER2-positive.

Trastuzumab, approved in 1998, is the most common medicine used to treat HER2-positive breast cancer. A targeted therapyinfo-icon that attacks a specific protein on the outside of cancer cells to prevent them from multiplying too quickly and causing cancer to grow, it is usually paired with chemotherapyinfo-icon.

Trastuzumab is given as an infusioninfo-icon through a vein, using either an IV or a port, and dosed according to your weight. The first treatment takes about 90 minutes, with later treatments lasting about 30 minutes.

While trastuzumab works well to treat HER2-positive cancers, these treatments can be time-consuming for many people. Finding a faster way to give the medicine can help. The trastuzumab shot, known as trastuzumab and hyaluronidase-oyst, may make appointments faster and easier for people eligible to get it.

The HannaH, SafeHER, and PrefHER Studies

The FDAinfo-icon approved the trastuzumab shot based on three research studies carried out in women with early-stage, HER2-positive breast cancer. The studies showed that the shot is as effective and safe as IV trastuzumab.


In the phase III HannaH study, nearly 600 participants with HER2-positive breast cancer received either

  • Standard IV trastuzumab before and after breast surgeryinfo-icon, or
  • trastuzumab shots before and after breast surgery

Both medicines were given with chemotherapy at set points during treatment.

Researchers found that when given over about 5 minutes, the trastuzumab shot was as safe and effective as the IV trastuzumab . They noted higher concentrations of trastuzumab in the blood when given by shot than when given by IV. In addition, more than 45 percent of people getting the shot had no invasive cancerinfo-icon cells in the breast at the time of surgery, compared to nearly 41 percent of people getting IV trastuzumab.


The SafeHER study looked at the safety and effectiveness of trastuzumab shots through two study groups:

  • one group treated using a single-use, prefilled injectioninfo-icon device
  • one group treated using a single-use needle filled from a medicine vial

Each study group had over 2,000 participants, and both groups received chemotherapy as part of treatment.

The most common side effects —observed in about 10 percent of participants — were similar to those that occur with standard IV trastuzumab. The researchers determined that SafeHER confirmed trastuzumab shots as safe as IV trastuzumab.


The third study, PrefHER, looked at participant preference for the two medications. A total of 488 participants were divided into two groups:

  • one group given four cycles of trastuzumab shots, followed by four cycles of IV trastuzumab
  • one group given the reverse: four cycles of IV trastuzumab, followed by four cycles of trastuzumab shots

The study found that 86 percent of people preferred the shot over the IV infusion. The main reason was time saved, since the shot can be given in under 5 minutes, versus about 30 minutes for infusion.

About Trastuzumab Shots

Trastuzumab and hyaluronidase-oyst is injected under the skin, typically into the thigh. Unlike IV trastuzumab, everyone gets the same doseinfo-icon with the shot – the dose is not based on your weight.

The FDA approved the medicine for early-stage, HER2-positive breast cancer at higher risk of recurring when:

  • cancer has traveled to the lymphinfo-icon nodes
  • the cancer has not traveled to the lymph nodes, but tests hormone receptorinfo-icon-negative or has one of the following features
    • a tumorinfo-icon larger than 2 centimeters
    • a gradeinfo-icon 2 or 3 tumor
    • occurs in someone younger than 35

In early-stage disease, the medicine should be given alongside approved chemotherapy, or after treatment with an anthracyline-based chemotherapy.

For metastatic breast cancer, trastuzumab shots can be used as a first treatment when combined with the chemotherapy paclitaxelinfo-icon. Shots can also be given without chemotherapy if a person has already had one or more courses of chemotherapy.

The trastuzumab shot has many of the same side effects as IV trastuzumab, including

  • fatigueinfo-icon
  • headache
  • diarrheainfo-icon
  • nauseainfo-icon
  • chills
  • fever 
  • risk of infectioninfo-icon
  • difficulty sleeping
  • joint and muscle pain
  • cough
  • rash
  • irritation at the injection site

Both medicines pose a rare but serious risk of heart problems that can usually be resolved by stopping the medicine or taking heart medicine. Serious lung problems also can occur, but they too are uncommon.

What This Means for You

If you have early-stage or metastatic HER2-positive breast cancer, news that trastuzumab shots can make each treatment session faster may excite you. Making time for breast cancer treatments is incredibly important, but many people struggle with the amount of time each treatment session requires. With the introduction of trastuzumab  shots, you may find treatment is less of a burden on your schedule.

Talk to your doctor to find out if you’re eligible for this new treatment. He or she will be able to look at your pathology reportinfo-icon and tell you whether you’re a good candidate for the medicine.

If you’re already being treated with IV trastuzumab, you might be able to switch to the injectable form. See what your treatment team recommends.

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