T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd

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NCT07683754 · readout in 1,414 d

Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca.

Phase

Phase 3

Status

Not yet recruiting

Study type

Interventional

Design

Na · None · Treatment

Enrollment

200estimated

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

2026-09-04

estimated

When the study began enrolling

Primary completion

2030-07-04

estimated

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

Study completion

2030-08-28

estimated

The whole study's end, after follow-up

First posted

2026-07-06

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-23

actual

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

What it studies

Conditions

Advanced Breast Cancer
Metastatic Breast Cancer
HER2 Positive
HR Positive

Interventions

Drug: Trastuzumab deruxtecan — also filed as T-DXd, ENHERTU®
Drug: Trastuzumab — also filed as Herceptin®
Drug: Pertuzumab — also filed as Perjeta®
Drug: Endocrine Therapy
Drug: Palbociclib — also filed as Ibrance®

Primary outcome

what the primary-completion date above is the date OF

Progression-free Survival (PFS) Rate at 24 Months

measured From start of Upfront Treatment phase until disease progression (PD) or death, whichever occurs first, up to approximately 24 months

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