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

Plain-language summary

This study examines various pre-surgery (neoadjuvant) treatments chosen according to the tumor's molecular subtype in patients with breast cancer. It enrolls patients aged 18-70 with histologically confirmed invasive breast cancer. The study is in Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Fudan University

Intervention

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)

Start date

11/1/2022

Estimated completion

9/1/2029

Countries

China

Related genes

Locations

• Shanghai, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.