NCT05582499 Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
| NCT ID | NCT05582499 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Breast Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 716 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 716 participants in total. It began in 2022-11-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Zhimin Shao, Professor
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05582499 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05582499 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05582499 currently recruiting?
Yes, NCT05582499 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT05582499 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05582499 clinical trial?
NCT05582499 is sponsored by Fudan University. The principal investigator is Zhimin Shao, Professor at Fudan University. The trial plans to enroll 716 participants.