NCT05744375

Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab

Phase II Trial of TRAstuzumab deruxtecaN in firSt-line Treatment of HER2-positive Locally advanCEd or Metastatic Breast caNcer (MBC) Patients Considered Resistant to Trastuzumab + Pertuzumab + Taxane Due to Early Relapse."TRANSCENDER Study"

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this national, multicenter single arm phase II clinical trial is to study the efficacy, safety and tolerability of the administration of Trastuzumab Deruxtecan (T-DXd) in HER2-positive locally advanced or metastatic breast cancer (MBC) patients resistant to trastuzumab plus pertuzumab plus taxane due to early relapse. The main questions it aims to answer are: * To evaluate the antitumor activity of T-DXd in the first-line treatment of HER2-positive breast cancer patients resistant to trastuzumab-pertuzumab based therapy. * To assess other efficacy measures. * To evaluate safety and tolerability in all patients enrolled in the study. * To evaluate health-related quality of life (HRQoL). Forty-one evaluable patients will be treated with trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV every 3 weeks (± 3 days). Patients will receive T-DXd until unacceptable toxicity, progressive disease, informed consent withdrawal, or other discontinuation criterion is met.

Detailed description

This is a national, multicenter single arm phase II clinical trial to study the efficacy, safety and tolerability of the administration of Trastuzumab Deruxtecan (T-DXd) in HER2-positive locally advanced or MBC patients resistant to trastuzumab plus pertuzumab plus taxane due to early relapse. Eligible patients will be enrolled and treated with T-DXd 5.4 mg/kg IV every 3 weeks. The T-DXd dose will be recalculated in the event that patients experience body weight variations greater than 10% during the treatment period. All patients enrolled will receive study therapy until radiographic or symptomatic progressive disease, unacceptable toxicity or withdraw of the informed consent, whatever occurs first. Study population: HER2-positive locally advanced or MBC patients who have not received prior chemotherapy or HER2 targeted therapy for advanced disease and with a Disease-Free Interval (DFI) of \<12 months from the end of prior (neo)adjuvant anti-HER2 therapy. Study Duration: The start date of the study is the date of the first site activation. Recruitment period will occur during approximately 24 months from the first patient in. The end date of the study is the date of the last visit of the last patient (LPLV), including follow-up. The duration of the study will be approximately 68 months from the first patient in. Performing exploratory objectives will be independent of the date of the end of the study.

Conditions

• Locally Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	All patients enrolled will be treated with trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV every 3 weeks (± 3 days). The subject's weight at baseline will be used to calculate the initial dose. If during the course of treatment the subject's weight changes by ± 10% of the baseline weight, the subject's dose will be recalculated based on the subject's updated weight. Patients will receive T-DXd until unacceptable toxicity, progressive disease (PD), informed consent withdrawal, or other discontinuation criterion is met.

Timeline

• Start date: 2023-09-28
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2023-02-27
• Last updated: 2026-04-02
• Results posted: 2026-03-12

Locations

19 sites across 1 country: Spain