A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Condition(s) studied
Investigational drug(s) / intervention(s)
Dato-DXd: Provided in 100mg vials. IV infusion. Experimental drug.
Durvalumab: Provided in 500mg vials. IV infusion. Experimental drug.
Paclitaxel: IV infusion. Active comparator.
Nab-paclitaxel: IV infusion. Active comparator.
Gemcitabine: IV infusion. Active comparator.
Carboplatin: IV infusion. Active comparator.
Pembrolizumab: IV infusion. Active comparator.
Study summary
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months).
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The comparison will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the participant progresses or dies immediately after 2 or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the 2 missed visits. The measure of interest is the HR of PFS.
Trial sites (318)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Daphne | Alabama | Recruiting |
| Research Site | Springdale | Arkansas | Recruiting |
| Research Site | Duarte | California | Withdrawn |
| Research Site | Fountain Valley | California | Not Yet Recruiting |
| Research Site | Glendale | California | Recruiting |
| Research Site | Sacramento | California | Recruiting |
| Research Site | Santa Rosa | California | Withdrawn |
| Research Site | Aurora | Colorado | Recruiting |
| Research Site | Denver | Colorado | Not Yet Recruiting |
| Research Site | New Haven | Connecticut | Recruiting |
| Research Site | Altamonte Springs | Florida | Not Yet Recruiting |
| Research Site | Jacksonville | Florida | Withdrawn |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Palm Bay | Florida | Withdrawn |
| Research Site | Plantation | Florida | Recruiting |
| Research Site | Atlanta | Georgia | Suspended |
| Research Site | Honolulu | Hawaii | Withdrawn |
| Research Site | Chicago | Illinois | Recruiting |
| Research Site | Decatur | Illinois | Withdrawn |
| Research Site | Elmhurst | Illinois | Withdrawn |
| Research Site | Naperville | Illinois | Withdrawn |
| Research Site | New Albany | Indiana | Withdrawn |
| Research Site | Des Moines | Iowa | Recruiting |
| Research Site | Lexington | Kentucky | Withdrawn |
| Research Site | Louisville | Kentucky | Withdrawn |
| Research Site | Louisville | Kentucky | Withdrawn |
| Research Site | Baton Rouge | Louisiana | Withdrawn |
| Research Site | Baton Rouge | Louisiana | Recruiting |
| Research Site | Baltimore | Maryland | Withdrawn |
| Research Site | Columbia | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Withdrawn |
| Research Site | Worcester | Massachusetts | Withdrawn |
| Research Site | Detroit | Michigan | Recruiting |
| Research Site | Grand Rapids | Michigan | Withdrawn |
| Research Site | Saint Paul | Minnesota | Recruiting |
| Research Site | Hattiesburg | Mississippi | Withdrawn |
| Research Site | St Louis | Missouri | Recruiting |
| Research Site | Albuquerque | New Mexico | Recruiting |
| Research Site | Albany | New York | Withdrawn |
| Research Site | New York | New York | Recruiting |
+ 278 more sites — see the full list on the official registry below.
More AstraZeneca trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06103864 on ClinicalTrials.gov ↗ ← All trials in South Korea