Fudan Üniversitesi Şanghay Kanser Merkezi Meme Kanseri Hassas Platform Seri Çalışması - Neoadjuvan Tedavi

Sade dilde özet

Bu çalışma, meme kanseri (breast cancer) hastalarında, tümörün moleküler alt tipine göre seçilen çeşitli ameliyat öncesi (neoadjuvan) tedavileri inceliyor. Çalışmaya, histolojik olarak doğrulanmış invaziv meme kanseri bulunan, 18-70 yaş arası hastalar alınmaktadır. Çalışma Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Fudan University

Müdahale

Dalpiciclib, Pyrotinib, SHR-A1811, SHR-1316, Camrelizumab, SHR-A1921, Pertuzumab, Trastuzumab, Goserelin, Letrozole, Nab paclitaxel, Carboplatin, Epirubicin, Cyclophosphamide, Fluzoparib, Apatinib, Famitinib, HB1801, LEM, TQB2102, Benmelstobart, Anlotinib, TQB2868, Ivonescimab, JS207, JSKN003, HRS-4508, SHR-4602, paclitaxel, HRS-6209, 9MW2821, IBI354, Stereotactic Body Radiation Therapy (SBRT)

Başlangıç

01.11.2022

Tahmini bitiş

01.09.2029

Ülkeler

China

İlgili genler

Merkezler

• Shanghai, China

Uygunluk kriterleri

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

Inclusion Criteria:

* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;
* Age between18-70 years;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* ER, PR and HER2 status were measured by immunohistochemistry (IHC);
* LVEF≥55%；
* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\&E slices;
* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;
* At least one measurable lesion according to RECIST version 1.1
* Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;
* Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
* Patients with severe systemic infections or other serious diseases;
* Patients with known allergy or intolerance to the study drug or its excipients;
* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;
* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;
* Patients who were judged by the investigator to be unsuitable for this study.