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Clinical trial results with DATROWAY

DATROWAY was studied in a clinical trial against chemotherapy.* The clinical trial included adults who received prior endocrine-based therapy and chemotherapy for HR+/HER2− breast cancer that was unresectable Cancer that cannot be removed by surgery. or metastatic.Cancer that has spread to other parts of the body.

About the trial

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The trial was conducted at research sites worldwide and was open-label, meaning both patients and doctors knew which treatment each patient received
732 people studied
People were treated with either DATROWAY (365 people) or chemotherapy (367 people)
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Patients must have received prior endocrine-based therapy and chemotherapy treatment for unresectable or metastatic disease
28-86 age range
The median age in the clinical trial was 55 years. This means about half of the patients were younger than 55, and about half were older

What the trial measured:

  • The primary endpoints for the patients from this trial were progression-free survival and overall survival
  • A primary endpoint is the main result that is measured at the end of a trial to see if a treatment worked
  • In addition to these, the trial also looked at the objective response rate and duration of response

*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).

HR=hormone receptor; HER2=human epidermal growth factor receptor 2.

*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).

HR=hormone receptor; HER2=human epidermal growth factor receptor 2.

In a clinical trial

DATROWAY helped keep tumors from growing and spreading

Progression-free survival results

Progression-free survival is the length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. This result was statistically significant, which means the result is unlikely to have occurred by chance alone. At the time of evaluation, fewer people on DATROWAY had their tumors grow or spread than on chemotherapy. Half of the people treated with DATROWAY didn't see their cancer grow or spread for 6.9 months vs. 4.9 months for those on chemotherapy.

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 on DATROWAY treatment.

A calendar graphic that says "6.9 MONTHS" within it.
median progression-free survival with DATROWAY
A calendar graphic that says "4.9 MONTHS" within it.
median progression-free survival with chemotherapy

Median progression-free survival is the amount of time from the start of treatment before half of the people had their cancer grow or spread.

In a clinical trial

How long people lived on DATROWAY and chemotherapy

Overall survival results

Overall survival is the amount of time that people in the trial lived since starting treatment. This result was not statistically significant, which means the result cannot be fully explained as an effect of the treatment alone. In a clinical trial, half of the people treated with DATROWAY were alive at 18.6 months and half of the people treated with chemotherapy were alive at 18.3 months.

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 on DATROWAY treatment.

A calendar graphic that says "18.6 MONTHS" within it.
median overall survival
with DATROWAY
A calendar graphic that says "18.3 MONTHS" within it.
median overall survival
with chemotherapy

Median overall survival is the amount of time that half of the people lived since starting treatment.

Additional trial results

Objective response rate results

Objective response rate is the percentage 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%. In a clinical trial, 36% of people had their tumors shrink with DATROWAY and 23% of people had their tumors shrink with chemotherapy.

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 on DATROWAY treatment.

How many people saw their tumors shrink on DATROWAY
or chemotherapy

0%

36% of people had their tumors shrink with DATROWAY

36% of people had a partial response and 0.5% had a complete response.

0%

23% of people had their tumors shrink with chemotherapy

23% of people had a partial response and 0% had a complete response.

Objective response rate was measured in 133 people on DATROWAY and 84 people on chemotherapy whose tumors could be measured.

Median duration of response is the amount of time half of the people who had a first response to treatment (cancer shrinking or not seen on imaging tests) had before their cancer grew or spread or they were no longer alive.

The median duration of response was 6.7 months with DATROWAY and 5.7 months with chemotherapy.

Objective response rate and median duration of response were not tested for statistical significance and the trial was not designed to show differences between treatments. Talk to your doctor if you have any questions.

Learn about possible
side effects Review the DATROWAY Getting Started Guide