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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06245824
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan (T-DXd) with pyrotinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 30, 2024
Status verified
Feb 2024
Primary completion
Mar 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All the subjects enrolled will receive the experimental intervention
    Participants will receive 5.4 mg/kg of T-DXd as IV infusion q3w, along with pyrotinib 400mg or 320mg (depend on recommended dose) orally once a day within 30 minutes after breakfast for a 21-day cycle.

Primary Outcome Measure

Progression free survival (PFS) based on investigator assessment [ Time Frame: Up to 49 months (data cut-off) ]

Central Contacts

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