Rational and trial design of FASCINATE-N: a prospective, randomized, precision-based umbrella trial.
Wen-Jia Zuo, Li Chen, Yu Shen...
https://pubmed.ncbi.nlm.nih.gov/38362377Actively Recruiting
Phase 2
Age: 18Years - 70Years
FEMALE
ID05582499
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
Led by Fudan University · Updated on 2026-05-28
716
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore precision neoadjuvant therapy in operable breast cancer patients who meet indications for neoadjuvant chemotherapy. It focuses on clinical subtypes to better tailor treatments by using updated translational research, including refined tumor typing, new target discoveries, and novel drug development. The study is a phase 2 platform trial designed to compare new drug therapies alone or combined with standard chemotherapy against standard therapy alone, based on molecular subtypes of breast cancer. Participants are assigned randomly to either a precision treatment group or a conventional neoadjuvant chemotherapy group according to their molecular subtype. Treatments include various novel targeted drugs and combinations, such as CDK4/6 inhibitors, anti-HER2 antibody-drug conjugates, anti-PD1 or PD-L1 antibodies, tyrosine kinase inhibitors, and stereotactic body radiation therapy (SBRT) prior to drug therapy in some subtypes. The study adapts over time, adding or dropping treatment arms based on ongoing research findings and biomarker signatures. During the study, participants will undergo assessments including pathological complete response rate (pCR) evaluation up to 24 weeks, gene expression profiling, peripheral blood mononuclear cell counts, and safety monitoring using CTCAE criteria for about one year. Additional outcomes include invasive disease-free survival tracked for three years post-surgery and overall response rate within 24 weeks. Participants will be monitored regularly with clinical and laboratory tests to evaluate treatment effects and safety throughout the trial.
CONDITIONS
Brief Title
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
Who Can Participate
Age: 18Years - 70Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0
- Age between 18 and 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Estrogen receptor (ER), progesterone receptor (PR), and HER2 status measured by immunohistochemistry
- Left ventricular ejection fraction (LVEF) 55% or higher
- Subtypes confirmed by digital pathology or triple-negative subtyping using AR, CD8, and FOXC1 markers
- At least one measurable lesion according to RECIST version 1.1
- Normal organ and marrow function including hemoglobin ≥ 90 g/L, neutrophil count ≥ 1500/µL, platelets ≥ 75,000/µL, bilirubin ≤ 1.5 x upper limit of normal, liver enzymes ≤ 3 x upper limit of normal, creatinine within normal limits, and creatinine clearance > 50 ml/min
- Non-pregnant and non-lactating female using medically approved contraception during and for 3 months after treatment
- Ability to understand and willing to sign written informed consent
You will not qualify if you...
- Previous cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason
- Heart disease classified as New York Heart Association grade II or above
- Severe systemic infections or other serious diseases
- Known allergy or intolerance to study drugs or their ingredients
- Other malignant tumors within the past 5 years except cured cervical carcinoma in situ and non-melanoma skin cancer
- Pregnant or lactating patients who do not use appropriate contraception
- Participation in another clinical trial within 30 days before the first study drug dose
- Any condition judged by investigators as unsuitable for this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks
Participants receive neoadjuvant therapy, which may include various novel drugs alone or in combination with standard chemotherapy based on their breast cancer subtype. Some participants may undergo stereotactic body radiation therapy (SBRT) to the primary tumor prior to drug treatment as part of their assigned regimen.
Multiple visits during treatment period
Follow-up
Duration - Three years post-surgery
Participants are followed post-surgery to monitor invasive disease-free survival and overall health status.
Regular follow-up visits over three years
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center Shanghai, China, 200032
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
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Research Team
Z
Zhimin Shao, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
63
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