HER2-pozitif İleri Meme Kanserinin Birinci Basamak Tedavisinde Disitamab Vedotin + Pyrotinib ile THP'nin Karşılaştırıldığı Klinik Çalışma

Sade dilde özet

Bu çalışma, HER2-pozitif ileri evre meme kanseri (breast cancer) olan hastaların birinci basamak (ilk) tedavisinde disitamab vedotin ile Pyrotinib kombinasyonunu, standart THP tedavisi (trastuzumab, Pertuzumab ve taksan) ile karşılaştırmaktadır. Çalışmaya, 18-75 yaş arası, daha önce metastatik hastalık için kemoterapi almamış, HER2-pozitif kadın hastalar alınmaktadır. Çalışma Faz 3 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Katılımcı alıyor

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Müdahale

disitamab vedotin, Pyrotinib, trastuzumab, Pertuzumab, taxane drug

Başlangıç

06.09.2023

Tahmini bitiş

30.06.2031

Ülkeler

China

İlgili genler

Merkezler

• Guangzhou, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Adult female patients (age 18-75 years) with metastatic breast cancer confirmed by pathology or imaging;
2. Pathologically confirmed HER2 positive (definition: Immunohistochemistry(IHC) 3+, or IHC 2+ and Fluorescent In Situ Hybridization(FISH) amplification);
3. No previous chemotherapy regimen for metastatic breast cancer;
4. At least one measurable lesion exists (Response Evaluation Criteria in Solid Tumors(RECIST) 1.1);
5. Eastern Cooperative Oncology Group(ECOG) performance status score ≤ 2 and expected survival of not less than 3 months;
6. Prior treatment-related toxicity at enrollment must have resolved to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) (version 5.0) ≤ 1 degree (except for alopecia or other toxicity that, in the judgment of the investigator, is not considered a risk to the safety of the patient);
7. Patients with adequate organ function before enrollment:

   1. White Blood Cell (WBC) ≥ 3.0 x 10\^9/L;
   2. Neutrophil granulocyte (ANC) ≥1.5 x 10\^9/L;
   3. Platelet (PLT) ≥70×10\^9/L;
8. Liver, kidney, and cardiac function tests are essentially normal (based on the normal values in the laboratory of each study center):

   1. Total bilirubin (TBIL) ≤ 3 x Upper Limit of Normal (ULN);
   2. Alanine aminotransferase (ALT/AST) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases);
   3. serum creatinine ≤ 1.5 x ULN or creatinine clearance (Ccr) ≥ 60 ml/min;
9. . Normal cardiac function;

   1. Left ventricular ejection fraction (LVEF) ≥ 55%;
   2. QT-interval corrected with Fridericia (QTcF) ≤ 470ms;
10. Hormone receptor status is clear;
11. Female patients of childbearing potential who have a negative pregnancy test and agree to use an effective non-hormonal method of contraception during treatment and for at least 6 months after the last dose of the test drug;
12. Able to understand the study process, voluntarily participate in this study, and sign an informed consent form.

Exclusion Criteria:

1. Pathology suggestive of HER2 negativity (IHC 2+ and FISH-, or IHC 1+);
2. Patients with known hypersensitivity to the active ingredient or other components of the study drug;
3. Patients during pregnancy or lactation, patients with childbearing potential tested positive in a baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial;
4. Patients not eligible for this study judged by the investigator, a pre-existing disease or condition that may interfere with participation in the study or any serious medical disorder that may interfere with the safety of the subject (e.g., uncontrolled heart disease, high blood pressure, active or uncontrolled infections, active hepatitis B virus infection).