A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

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NCT04538742

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo Company, Limited.

Phase

Phase 1/2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

245actual

Sites

Countries

Australia, Brazil, Canada +12

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2020-12-28

actual

When the study began enrolling

Primary completion

2025-01-31

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-01-31

estimated

The whole study's end, after follow-up

First posted

2020-09-04

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-12-08

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Metastatic Breast Cancer

Interventions

Drug: Trastuzumab deruxtecan — also filed as DS-8201a, T-DXd
Drug: Durvalumab — also filed as MEDI4736
Drug: Paclitaxel
Drug: Pertuzumab
Drug: Tucatinib — also filed as ONT-380

Primary outcomes

what the primary-completion date above is the date OF

Occurrence of adverse events (AEs)- Part 1

measured Up to follow-up period, approximately 53 months

Occurrence of serious adverse events (SAEs)- Part 1

measured Up to follow-up period, approximately 53 months

Occurrence of adverse events (AEs)- Part 2

measured Up to follow-up period, approximately 53 months

Occurrence of serious adverse events (SAEs)- Part 2

measured Up to follow-up period, approximately 53 months

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