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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

NCT07683754 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-23

No results posted yet for this study

Summary

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

Conditions

Interventions

DRUG

Trastuzumab deruxtecan

Upfront treatment: One IV infusion Q3W 5.4 mg/kg (starting dose) on Day 1 of each 21-day cycle T-DXd Retreatment: One IV infusion Q3W 5.4 mg/kg (starting dose) on Day 1 of each 21-day cycle \*Dose reductions implemented during Upfront treatment phase will be maintained.

DRUG

Trastuzumab

Maintenance treatment: One IV infusion Q3W 6 mg/kg on Day 1 of each 21-day cycle

DRUG

Pertuzumab

Upfront treatment: One IV infusion Q3W loading dose of 840 mg, then 420 mg Q3W thereafter on Day 1 of each 21-day cycle Maintenance treatment: One IV infusion Q3W 420 mg on Day 1 of each 21-day cycle

DRUG

Endocrine Therapy

Aromatase inhibitors or fulvestrant administered as approved product label

DRUG

Palbociclib

Maintenance treatment: Daily (3 out of 4 weeks, Q4W) oral 125 mg

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-04
Primary Completion
2030-07-04
Completion
2030-08-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07683754 on ClinicalTrials.gov