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Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial

NCT06245824 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-02-07

No results posted yet for this study

Summary

This is an exploratory, single-arm, multi-center study to assess the efficacy and safety of T-DXd combined with pyrotinib as the first-line treatment of HER2-positive metastatic breast cancer.

This study is planned to recruit 3 to 12 patients in safety run-in (Part A) and 39 to 42 patients in dose expansion (Part B) in several investigational sites in China. The total number of patients enrolled in the study will be 45 to 51. Among them, 45 patients will start at the recommended dose. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive T-DXd combined with pyrotinib until confirmed progressive disease. Patients will attend a safety follow up visit 40 days after last dose of T-DXd with pyrotinib. There are two main parts to this study; Part A, Combination dose finding and Parts B, Dose expansion.

Tumor assessments will be performed at Screening as baseline with follow-up every 9 weeks(±7 days) from the date of first dosing date of T-DXd with pyrotinib for 54 weeks, and then every 12 weeks (±7 days) until confirmed objective disease progression.

Primary Objective for Part A:

To define the recommended dose of pyrotinib combined with T-DXd Recommended dose

Secondary Objective for Part A:

To investigate the safety and tolerability of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer.

Primary Objective for Part B :

To determine the efficacy of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer.

Secondary Objective for Part B :

To further determine the efficacy of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer and To further evaluate the safety and tolerability profile of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer.

Conditions

Interventions

DRUG

Trastuzumab deruxtecan (T-DXd) with pyrotinib

T-DXd, 5.4mg/kg IV day 1 of a 21-day cycle. Pyrotinib, 400mg or 320mg, orally once a day, daily of a 21-day cycle.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Binghe Xu · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2026-03-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06245824 on ClinicalTrials.gov