T-DXd Versus THP for Medium-risk HER2-positive Early Breast Cancer

Sponsor
Fudan University
Study ID
NCT06548178
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • T-DXd — DRUG
    T-DXd (5.4 mg/kg Q3W on Day 1) ×6 cycles.
  • THP — DRUG
    Docetaxel (75 mg/m2 Q3W on Day 1) concurrent with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) and pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) × 6 cycles.

Study Details

This study (EXTEND trial) is a multicentre, interventional, prospective, randomised, open-label, controlled neoadjuvant, phase 2 trial evaluating the efficacy and safety of T-DXd monotherapy vs. standard-of-care docetaxel+ trastuzumab + pertuzumab (THP) in medium-risk (lymph node negative with a primary tumour stage T2) HER2-positive early breast cancer.

Key Dates

First listed
Aug 12, 2024
Start date
Sep 30, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2028

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    T-DXd (5.4 mg/kg Q3W on Day 1) ×6 cycles.
  • Placebo Comparator: Arm B
    Docetaxel (75 mg/m2 Q3W on Day 1) concurrent with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) and pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) × 6 cycles.

Primary Outcome Measure

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery [ Time Frame: Up to approximately 1 year ]

Central Contacts

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