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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

ConditionsAdvanced Breast CancerMetastatic Breast CancerHER2 PositiveHR Positive
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.

Participant must be ≥18 years of age at the time the ICF is signed.

Is locally advanced and unresectable or metastatic (participants who can be treated with curative intent are not eligible).

Participant must have histologically confirmed HER2+ and HR+ (ER+ and/or PR+), mBC. ER, PR, and HER2 measurements should be locally performed according to institutional guidelines.

Disqualifiers

Has prior therapy with any CDK inhibitor.

Previous T-DXd therapy for early BC with an EFS or disease-free interval of < 12 months from completion of T-DXd therapy in the neoadjuvant or post-neoadjuvant setting.

Is receiving concurrent therapy with other trial interventions (except pertuzumab which is part of Upfront Treatment and Maintenance Treatment).

Has prior therapy with any CDK inhibitor.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Trastuzumab deruxtecan

    Drug

    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.

  • Trastuzumab

    Drug

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

  • Pertuzumab

    Drug

    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

  • Endocrine Therapy

    Drug

    Aromatase inhibitors or fulvestrant administered as approved product label

  • Palbociclib

    Drug

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: T-DXdExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) Rate at 24 Months

PFS is defined as the time from initiation of T-DXd + pertuzumab until PD or death, whichever occurs first.

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

Secondary outcomes

1

Progression-free Survival (PFS) Rate at 12 Months

PFS is defined as the time from initiation of T-DXd + pertuzumab until PD or death, whichever occurs first.

Time frame
From start of Upfront Treatment phase until disease progression (PD) or death, whichever occurs first, up to approximately 12 months
2

Objective Response Rate

ORR is defined as the proportion of participants with measurable disease at baseline who have a CR or PR during the Upfront Treatment Phase.

Time frame
From start of Upfront Treatment phase until disease progression (PD) or death, whichever occurs first, up to approximately 24 months
3

Progression-free Survival (PFS) Rate From Start of Maintenance Treatment at 12 Months

PFS from start of Maintenance Treatment is defined as the time from initiation of Maintenance Treatment until PD or death, whichever occurs first.

Time frame
From start of Maintenance Treatment until disease progression (PD) or death, whichever occurs first, up to approximately 12 months
4

Overall Survival at 24 Months

OS is defined as the time from initiation of T-DXd + pertuzumab until the date of death due to any cause.

Time frame
From start of Upfront Treatment phase until the date of death, up to approximately 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: