Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT05582499

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

Led by Fudan University · Updated on 2025-08-22

716

Participants Needed

1

Research Sites

304 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed invasive breast cancer at clinical stage II (T2N0-1M0/T3N0M0) or III (T2N2M0/T3N1-2M0)
  • Age between 18 and 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • ER, PR, and HER2 status measured by immunohistochemistry
  • Left ventricular ejection fraction (LVEF) of 55% or higher
  • SNF subtypes confirmed by digital pathology of H&E slices
  • Triple-negative breast cancer 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 (no transfusion within 14 days), absolute neutrophil count ≥ 1500/µL, platelets ≥ 75,000/µL, total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 3 x ULN, creatinine < 1 x ULN, and creatinine clearance > 50 ml/min
  • Non-pregnant and non-lactating females using an approved contraceptive method during treatment and for at least 3 months after last study drug use
  • Ability to understand and willingness to sign written informed consent
Not Eligible

You will not qualify if you...

  • Prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason
  • New York Heart Association (NYHA) grade II or higher heart disease
  • Severe systemic infections or other serious diseases
  • Known allergy or intolerance to study drugs or their excipients
  • Other malignancies within the past 5 years, except cured cervical carcinoma in situ or non-melanoma skin cancer
  • Pregnant or lactating patients who refuse to use appropriate contraception during the study
  • Participation in other clinical trials within 30 days before first study drug dose
  • Investigator judgment deeming the patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

53

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