Precision neoadjuvant therapy for operable breast cancer

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)

This study is testing if a personalized treatment approach using new drugs for operable breast cancer can work better than standard chemotherapy alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 716 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05582499 on ClinicalTrials.gov

What this trial studies

This study aims to establish a platform for precision neoadjuvant therapy in patients with operable breast cancer, focusing on clinical subtypes. It will compare the efficacy of novel drugs, either alone or in combination with standard chemotherapy, against standard therapy alone. Eligible patients will be randomly assigned to either a precision treatment group or a conventional chemotherapy group based on their molecular typing. The trial will adapt over time, incorporating new findings from translational research to refine treatment regimens and identify effective biomarker signatures.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 with histologically confirmed invasive breast cancer at clinical stages II or III.

Not a fit: Patients with non-invasive breast cancer or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with operable breast cancer.

How similar studies have performed: Other studies have shown promise in using precision medicine approaches for breast cancer, suggesting potential for success in this novel platform.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center Shanghai, China, 200032 — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhimin Shao, Professor — Fudan University
• Study coordinator: Zhimin Shao, Professor

Conditions Breast Neoplasm; Breast Cancer; Breast Tumors; Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor