Results of the CREATE-X trial

SABCS 2015

8 - 12 Dec 2015

Published: 14 Dec 2015

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Dr Masakazu Toi - Kyoto University, Kyoto, Japan

Dr Toi talks to ecancertv at SABCS 2015 about the results of the CREATE-X phase III clinical trial that have shown that capecitabine improves survival outcomes in women with HER2-negative breast cancer who have invasive disease after neoadjuvant chemotherapy.

In the interview, Dr Toi explains that women who do not achieve a pathological complete response (pCR) after neoadjuvant chemotherapy with an anthracycline and a taxane have an intermediate or high-risk for relapse. The CREATE-X trial was designed to see if further systemic chemotherapy with capecitabine would be beneficial for these patients.

Dr Toi and colleagues have previously reported data to show that adding capecitabine to standard adjuvant radiotherapy or hormone therapy was feasible and well tolerated. The findings presented at SABCS 2015 showed that the addition also improved the primary endpoint of 2-year disease-free survival by about 32% (87.3% vs 80.5%, p=0.001) and the secondary endpoint of overall survival (96.2% vs 93.9%, p=0.086) by about 35% versus standard adjuvant therapy alone.

Tolerability was consistent with the established safety profile of capecitabine in metastatic breast cancer and the results suggest there may be a role for capecitabine in some women after neoadjuvant chemotherapy.

ecancer's filming at SABCS 2015 has been kindly supported by Novartis through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.

We reported the results of the clinical trial named CREATE-X where we compared the standard treatment and the capecitabine treatment plus standard for the patients who have residual disease after neoadjuvant chemotherapy. These patients are basically poor prognostic, have a higher discovery recurrence, that we just wanted to see how the capecitabine treatment is effective to improve survival outcomes.

Were these triple negative patients?

Actually we had some negative patients: the luminal disease, the hormone receptor positive and the triple negative patients were included.

Why did you choose capecitabine?

That’s the big question. After neoadjuvant chemotherapy with anthracycline and a taxane still we have not so many, but not so small, we have some patients who don’t have the pCR. So potentially they are resistant to anthracycline and taxane. The capecitabine is a agent so we chose the capecitabine in this particular trial.

What was the outcome?

The outcome and the disease free survival was the endpoint. It was the big different in terms of the disease free survival in favour of the capecitabine arm.

What are the implications?

Presumably it’s possible to think about other therapeutic options for such patients having the high risk for recurrence after neoadjuvant chemotherapy.

What will be the options?

We have some limitations about the reimbursement in each country. So I cannot say it is quite possible but it can be a possible option for such patients. In terms of the overall survival outcome it was also significantly different. So the capecitabine treatment is able to prolong the disease free survival but also overall survival. That is the big outcome of this trial and almost in all subgroups we could see the benefit of capecitabine. That’s another important aspect of the capecitabine treatment.