Clinical Trial Data in HER2+ Breast Cancer


Virginia Kaklamani, MD, DSc, provides an overview of the goals of care for HER2+ breast cancer.

Matthew Fowler: You’ve touched on this subcutaneous administration. Could you briefly describe the data from the FeDeriCa trial that supported this subcutaneous approval?

Virginia Kaklamani, MD, DSc: Absolutely. The FeDeriCa trial is a phase 3 clinical trial that looked at neoadjuvant chemotherapy, including trastuzumab and pertuzumab IV [intravenously], versus the neoadjuvant chemotherapy with the subcutaneous trastuzumab and pertuzumab in the form of Phesgo. Patients completed the neoadjuvant part of their therapy, and then the pathologic complete response rate was looked at between the 2 treatment arms, the IV versus the subcutaneous arm. They found that the outcomes were identical between the arms. The subcutaneous injection worked as well as the IV injection. They also looked at the concentration of trastuzumab and pertuzumab in the blood. They found that the subcutaneous injection had higher levels of trastuzumab and pertuzumab compared to the IV injection. But I would look at the clinical outcomes, and those are identical between the 2 arms.

Matthew Fowler: What is the FDA-approved indication for this subcutaneous injection?

Virginia Kaklamani, MD, DSc: It’s very simple. The indication mirrors the indication for the IV preparation. Any time that you are going to use an IV trastuzumab/pertuzumab combination, you can use the subcutaneous preparation.

Matthew Fowler: Let’s look at the PHranceSCa study. Could you share some insights into this trial on patient preference in terms of the administration route of HER2-targeted therapy?

Virginia Kaklamani, MD, DSc: The PHranceSCa regimen was a patient preference trial where patients were given either IV or subcutaneous therapy, and then they were switched to either the subcutaneous or the IV. We found on that trial that 85% of women would rather get the subcutaneous than the IV preparation. The other 15% preferred the IV administration, and the reason seemed to be just a local reaction from the subcutaneous shot because the subcutaneous shot is given in the thigh, so there was some irritation. There was actually 1% of patients who had no preference between the two.

Matthew Fowler: Has your experience in the clinic mirrored what you saw here in this study, or did you find something different?

Virginia Kaklamani, MD, DSc: I haven’t treated 100 patients yet, but what I can tell you is that the majority of patients prefer the subcutaneous regimen. There was 1 patient who said she’d rather do the IV, and there were a few patients who didn’t want to switch. Without trying the subcutaneous regimen, they just said, “I’m fine with the IV.” But the majority of women were very welcoming of the switch. We could take their port out, which is always something that irritates patients. They were welcoming the fact that they didn’t have to have a port, and their subcutaneous shot time was much shorter than the infusion time with the IV.

Matthew Fowler: How has the COVID-19 pandemic influenced your treatment decisions across patients with HER2-positive breast cancer?

Virginia Kaklamani, MD, DSc: COVID-19 has made things a little harder. It hasn’t necessarily changed things too much in the HER2-positive world, just because we know that this is such an aggressive disease. We have to really follow the guidelines and treat appropriately. But the longer a patient spends in the infusion room, the higher their risk of exposure to COVID-19, and the higher their risk of exposing others if they happen to have COVID-19. We’ve tried to decrease the time that they spend in the infusion room and having a subcutaneous preparation available has been a welcoming change for us. Overall, as far as treating patients with HER2-positive disease, we haven’t made many changes since the beginning of the pandemic.

Transcript edited for clarity.

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