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Study of Paclitaxel Polymeric Micelles Combined With HP and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer

NCT07581795 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-12

No results posted yet for this study

Summary

This study is a randomized, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the efficacy and safety of paclitaxel polymer micelles for injection combined with trastuzumab and adalimumab versus the paclitaxel-based regimen combined with trastuzumab as first-line treatment.

Eligible subjects with histologically or cytologically confirmed advanced HER2-positive breast cancer were enrolled after obtaining informed consent. They were randomly assigned to two groups: the experimental group received paclitaxel polymer micelles for injection combined with trastuzumab, pertuzumab, and adrelumab; the control group received taxanes (paclitaxel, docetaxel, albumin-bound paclitaxel, paclitaxel polymer micelles) combined with trastuzumab and pertuzumab. Each treatment cycle lasted 3 weeks (Q3W), with administration on day 1 (D1) of each cycle. Therapy continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of alternative antitumor therapy, death, or any other treatment discontinuation criteria specified in the protocol-whichever occurred first.

Conditions

  • Advanced HER2-positive Breast Cancer

Interventions

DRUG

Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab

1. Paclitaxel polymer micelles for injection: 300 mg/m², administered via intravenous infusion over ≥3.5 hours; 2. Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours; 3. Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours; 4. Adalimumab: 20 mg/kg, with infusion duration controlled between 30 to 60 minutes, not exceeding 2 hours.

DRUG

Taxanes combined with trastuzumab and pertuzumab.

1. Paclitaxel: 175 mg/m², intravenous infusion over 3 hours; or Docetaxel: 75 mg/m², intravenous infusion over 1 hour; or Albumin-bound paclitaxel: 260 mg/m², intravenous infusion over 30 minutes; or Paclitaxel polymer micelles for injection: 300 mg/m², intravenous infusion over ≥3.5 hours. 2. Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours; 3. Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours;

Sponsors & Collaborators

  • Nanchang People's Hospital

    collaborator UNKNOWN

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Zhejiang Tumor Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-02-28
Completion
2031-03-31

Countries

  • China

Study Locations

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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 NCT07581795 on ClinicalTrials.gov