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About the trial
As you look through the trial results for DATROWAY, here are important points to note:
- The trial was also open-label, meaning that both the people being treated and trial investigators knew which treatments were received. Therefore, the results could have been influenced by people switching to another treatment, leaving the study, or other factors
- People were treated with either DATROWAY or a chemotherapy treatment*
- At the time of data analysis, people in the trial were monitored for about 11 months after they started treatment. This is called the median duration of follow-up
- Median is the middle number in a set of numbers. It is used to give an accurate picture of a range of data
*Doctor’s choice of chemotherapy (60% of patients received eribulin, 21% of patients received capecitabine, 10% of patients received vinorelbine, and 9% of patients received gemcitabine).
*Doctor’s choice of chemotherapy (60% of patients received eribulin, 21% of patients received capecitabine, 10% of patients received vinorelbine, and 9% of patients received gemcitabine).
Results with DATROWAY
Please remember that the results you will see are from a clinical trial and each person’s experience may differ. Speak with your doctor about what you may expect.
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Median progression-free survival results
A median is the middle number in a set of numbers. Median progression-free survival is the amount of time that half of the people enrolled in the trial were on treatment before their cancer started growing or spreading.
How long people lived on treatment without their cancer growing or spreading
median progression-free survival with DATROWAY
median progression-free survival with chemotherapyAt the time of evaluation, the median progression-free survival results were considered statistically significant. In a trial, results are considered statistically significant if they are unlikely to have occurred by chance alone, showing that the treatment likely had a real effect. -
Median overall survival results
A median is the middle number in a set of numbers. Median overall survival is the amount of time that half of the people in the trial lived since starting treatment.
How long people lived on DATROWAY and chemotherapy
18.6 months median overall survival with DATROWAY18.3 months median overall survival with chemotherapyOverall survival results were not statistically significant. In a trial, results are considered statistically significant if they are unlikely to have occurred by chance. Therefore, these results cannot be fully explained as an effect of the treatment alone. -
Overall response rate (tumor shrinking) results
This is the proportion of people who have a partial or complete response to therapy. A complete response means the tumor could not be seen on imaging tests. A partial response means the tumor shrank by at least 30%.
Response to treatment with DATROWAY and chemotherapy
36%
of people had their tumors shrink with DATROWAY
36% of people had a partial response and 0.5% had a complete response.
23%
of people had their tumors shrink with chemotherapy
23% of people had a partial response and 0% had a complete response.
Median duration of response (mDOR) is the length of time half of the people who responded to DATROWAY (partial or complete) continued to respond after the first response was seen. mDOR was about 6½ months with DATROWAY. mDOR was about 5½ months with chemotherapy.
Frequently asked questions
Want to know more?
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Q: Does the overall survival not being statistically significant mean the treatment didn’t work?
Even though the overall survival was not statistically significant, DATROWAY has been shown to significantly slow down the growth or spread of cancer. Ask your doctor about how treatment with DATROWAY may impact you given your specific history.
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Q: Why was DATROWAY tested against chemotherapy and not another medicine?
Traditional chemotherapy has been used to effectively treat people with metastatic breast cancer for over 20 years. Since chemotherapy is a common treatment given to this population of people, DATROWAY was studied against it.
HR=hormone receptor; HER2=human epidermal growth factor receptor 2.
