A fixed-dose combination of Herceptin (chemical name: trastuzumab) and Perjeta (chemical name: pertuzumab) given subcutaneously (under the skin) along with chemotherapy before surgery seems to offer the same benefits as intravenous (IV) infusions of the two medicines for people diagnosed with stage II to stage IIIC HER2-positive breast cancer.
The results were presented on Dec. 12, 2019, at the 2019 San Antonio Breast Cancer Symposium. Read the abstract of “Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study.
Doctors call treatment given before surgery neoadjuvant treatments.
About subcutaneous Herceptin and Perjeta
Both Herceptin and Perjeta are HER2 inhibitors. They work against HER2-positive breast cancer by blocking the chemical signals that tell the cancer cells to grow.
Traditionally, Herceptin and Perjeta are given intravenously, which means they’re delivered directly into your bloodstream through an IV or a port. The first dose of both medicines takes about an hour to complete. After that, it takes 30 to 60 minutes to get each dose.
The subcutaneous version of Herceptin and Perjeta combines fixed doses of the two medicines, plus hyaluronidase, an enzyme that helps the body absorb the medicines, in one vial. The combination of Herceptin, Perjeta, and hyaluronidase is injected into a person’s thigh over 5 to 8 minutes, so the time to receive each dose is much shorter.
About the study
This study, called the FeDeriCa study, wanted to figure out if giving Herceptin and Perjeta subcutaneously was as safe and effective as giving the medicines through an IV.
The study included 500 people diagnosed with stage II to stage IIIC HER2-positive breast cancer. The people were randomly assigned to one of two treatment regimens before surgery:
- chemotherapy plus IV Herceptin and Perjeta (252 people)
- chemotherapy plus subcutaneous Herceptin and Perjeta (248 people)
Overall, 96% of the people treated with IV Herceptin and Perjeta and 94.4% of people treated with subcutaneous Herceptin and Perjeta completed treatment before surgery.
The people then had surgery to remove any remaining cancer.
The researchers looked at the rates of pathologic complete response in both groups to see if there were any differences in effectiveness between the two types of Herceptin and Perjeta.
One way for doctors to judge the effectiveness of neoadjuvant treatment is to look at the tissue removed during surgery to see if any active cancer cells are present. If no active cancer cells are present, it’s called a “pathologic complete response,” or pCR.
The study found that pathologic complete response rates were almost identical between the two treatment groups. Pathologic complete response rates were:
- 59.5% for people treated with IV Herceptin and Perjeta
- 59.7% for people treated with subcutaneous Herceptin and Perjeta
The researchers also measured levels of Perjeta in people’s bodies in the two treatment groups and found they also were very similar.
The researchers also looked to see if giving Herceptin and Perjeta subcutaneously would cause any different or more severe side effects than the IV versions of the medicines.
There were no differences in side effects, and rates of specific side effects were similar in each treatment group. The most common side effects and rates in each treatment group were:
- hair loss: 70.2% in the IV group vs 77.0% in the subcutaneous group
- nausea: 60.3% in the IV group vs 58.9% in the subcutaneous group
- diarrhea: 55.2% in the IV group vs 58.5% in the subcutaneous group
About 18% of people in the IV group had a serious side effect compared to 16% of people in the subcutaneous group.
Both Herceptin and Perjeta are known to cause heart problems, but the study had very low rates of heart issues: 3.6% for the IV group and 1.6% for the subcutaneous group.
What this means for you
The results of this study are exciting and could offer people diagnosed with early-stage HER2-positive breast cancer a more convenient and faster treatment option for neoadjuvant targeted therapy.
Still, the subcutaneous version of Herceptin and Perjeta is not available outside a clinical trial yet. Roche, the company that makes the subcutaneous version of Herceptin and Perjeta has said that it plans to submit the data from the FeDeriCa study to health agencies around the world, including the U.S. Food and Drug Administration.
Stay tuned to Breastcancer.org for the latest information on any approvals for subcutaneous Herceptin and Perjeta.
To talk with others who have been diagnosed with HER2-positive breast cancer, join the Breastcancer.org Discussion Board forum HER2+ (Positive) Breast Cancer.
Written by: Jamie DePolo, senior editor