Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Launched by FUDAN UNIVERSITY · Oct 13, 2022

Keywords

ClinConnect Summary

This clinical trial, based at Fudan University Shanghai Cancer Center, is investigating new targeted therapies for women with operable breast cancer, specifically those with early-stage or locally advanced forms, including types like triple-negative and HER2-positive breast cancer. The goal is to find more precise treatment options that can improve outcomes for patients who need chemotherapy before surgery. Researchers will closely monitor how well these new treatments work and may discover new ways to better target the cancer.

To participate in this study, women aged 18 to 70 with confirmed invasive breast cancer at certain stages may be eligible, as long as they have good overall health and meet specific testing criteria. Participants can expect regular check-ups and treatments as part of the trial, and they will need to agree to follow certain health guidelines throughout the study. It's important to note that those who have had prior chemotherapy or have specific heart or serious health issues may not qualify. This study aims to improve treatment options for breast cancer and offers a chance to be part of cutting-edge research.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed invasive cancer of the breast and meet the clinical stage II（T2N0-1M0/T3N0M0）or III（T2N2M0/T3N1-2M0) criteria;
• • 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.