Design and interim safety analysis of GeparX trial

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Published: 4 Jun 2018
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Prof Sibylle Loibl - German Breast Cancer Group, Frankfurt, Germany

Dr Loibl speaks with ecancer at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting about the trail arms and early indications from the Gepar X trial investigating denosumab as a neoadjuvant treatment for RANK/L-positive or RANK/L-negative primary breast cancer and two different nab-paclitaxel schedules.

Dr Loibl also spoke with ecancer about the Gepar Nuevo trial, here

ecancer's filming has been kindly supported by Amgen through the ecancer Global Foundation. ecancer is editorially independent and there is no influence over content.

ecancer's filming has been kindly supported by Amgen through the ecancer Global Foundation. ecancer is editorially independent and there is no influence over content.

The GeparX study is also a neoadjuvant study in all-comers of early breast cancer patients, so triple negative, HER2 positive and luminal breast cancer patients are enrolled.

There are two main questions: first, the addition of durvalumab to an anthracycline taxane based chemotherapy, does it play a role; does it increase PCR rates?

We have seen here denosumab studies in early breast cancer going in one or the other direction.

The second question: what is the best schedule for nab-paclitaxel, the weekly 125mg or the schedule where you give the nab-paclitaxel on days 1 and 8 and then pause on day 15.

So in two out of three weeks schedule. So these are the main questions.

Another investigation we are doing in the GeparX is looking at the biosimilar added to pertuzumab which we investigate in 150 patients the safety profile and the efficacy in this combination because there haven’t been many combinations with biosimilars added to pertuzumab so far.

What we see is that when we look at the safety profile denosumab is very safe, it doesn’t add anything to the toxicity we observed with the chemotherapy.

What we see is that the two out of three regimen seems to be slightly better tolerated, especially in terms of sensory neuropathy.

But what we also see, because we add carboplatin in the triple negative breast cancer patients that this adds to the toxicity, especially the hematologic toxicity.

But otherwise the toxicity profile is as expected and the study, hopefully, will continue as planned after we have presented the data to the IDMC.