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Not yet recruiting NCT07047755

Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC

Phase II Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trastuzumab Rezetecan, Pertuzumab.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Open-label, Phase II Trial

Overview

This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.

Detailed description

Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Interventions

  • Drug Trastuzumab Rezetecan
    Trastuzumab Rezetecan
  • Drug Pertuzumab
    Pertuzumab

Primary outcome measures

  • pCR rate [Time frame: At the time of surgery]
Secondary outcome measures (4)
  • iDFS [Time frame: Up to approximately 5 years]
  • EFS [Time frame: Up to approximately 5 years]
  • ORR [Time frame: Up to approximately 24 weeks after the first administration]
  • AEs [Time frame: From the first dose until 30 days after last dose]

Eligibility criteria

Inclusion criteria

  • Female patients aged 18-70 years;
  • Histopathologically confirmed HER2 positive breast cancer;
  • Patients were diagnosed with stage II-III breast cancer;
  • At least one measurable target lesion according to RECIST V1.1;
  • ECOG performance status score of 0 to 1;
  • Life expectancy ≥12 weeks;
  • Adequate bone marrow reserve and organ system function reserve;
  • Participants should be able and willing to comply with the study protocol requirement;

Exclusion criteria

  • Breast cancer not histologically confirmed;
  • Known inherited or acquired bleeding and thrombotic tendencies;
  • Known allergy or contraindication to the study drug and its excipients;
  • Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
  • Concurrent receipt of any other form of anti-cancer therapy;
  • History of a second primary malignancy, except for adequately treated skin cancer;
  • Participation in other drug clinical trials within 4 weeks before enrollment;
  • Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
  • Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
  • Uncontrolled or significant cardiovascular and cerebrovascular diseases;
  • Subjects with known or suspected interstitial pneumonia;
  • Presence of active hepatitis B, hepatitis C, liver cirrhosis;
  • Pregnant or lactating female patients;
  • History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07047755 · HELEN-027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗