Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
Recruiting
Phase 2Interventional Study
Breast NeoplasmBreast CancerBreast TumorsTriple-Negative Breast Cancer (TNBC)HER2-positive Breast CancerHER2-negative Breast CancerHormone Receptor Positive TumorHormone Receptor Negative TumorEarly-stage Breast CancerLocally Advanced Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
716 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for people with operable breast cancer to explore a new treatment approach. Participants will receive a targeted therapy before surgery and help researchers understand how effective it is.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with invasive breast cancer stage T1-4N1-3M0 or cT2-4N0M0
I am between 18 and 70 years old
I have a performance status of 0-1
I have measurable lesions according to standard criteria
I have normal organ and marrow function
I am not pregnant or breastfeeding and will use contraception during the study
I can understand and sign a consent form
You may not be able to join if
I have received previous chemotherapy, hormone therapy, or radiation
I have heart disease that is classified as NYHA grade II or above
I have severe infections or other serious diseases
I am allergic or intolerant to the study drug or its components
I have had other cancers in the last 5 years, except for certain cured cancers
I am pregnant or breastfeeding and refuse to use contraception
I participated in other trials within the last 30 days
I have been judged by the investigator to be unsuitable for this study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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%;
* Definiti…
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.
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