Clinical trial NCT06510465: Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)
Official title: Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
utidelone
cisplatin
neoadjuvant therapy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

Detailed description: Explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in high risk early, locally advanced and Inflammatory breast cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Primary invasive breast cancer confirmed by pathology; Before neoadjuvant therapy, the primary breast lesion was larger than 2cm(cT2-T4a-d, according to the anatomical staging of AJCC 8th edition), or the clinical images of lymph nodes considered metastasis or pathologically confirmed metastasis (CN+); or patients whose primary breast lesions are more than 1cm and less than 2cm, and whose lymph nodes have not metastasized (cT1cN0) must meet one of the following conditions: hormone receptor negative, HER2 positive, or ki67 greater than 20%. If bilateral breast cancer is found at the same time, it can be admitted to the group, but it is necessary to determine which side of the lesion is to be evaluated before taking the drug;
3. According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;
4. The score of ECOG is 0 or 1;
5. During neoadjuvant therapy, ovarian function suppression can be given at the same time;
6. The hematological examination and blood biochemical examination should meet the following requirements: white blood cell count (WBC)≥3.0×109/L, neutrophil count (ANC)≥1.5×109/L and platelet count (PLT) ≥ 75× 109/L; Hemoglobin (HB) ≥ 80g/L; Total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN), AST(sGOT), ALT(sGPT)≤2×ULN and creatinine (Cr) ≤ 1.5× ULN;
7. creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);
8. Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.

Exclusion Criteria:

1. Patients during pregnancy and lactation, patients with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;
2. There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;
3. There is evidence of sensory or motor nerve diseases;
4. Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;
5. allergic to the research drug or its auxiliary materials;
6. Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of the study;
7. Previous history of other malignant tumors, except the cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and the second primary malignant tumor with high 5-year recurrence-free survival rate determined by researchers;
8. According to the researcher's judgment, there are accompanying diseases (including but not limited to uncontrollable hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study, and any other circumstances that the researcher judges that the patient is not suitable for participating in this study.

Primary outcomes:
measure: pCR
timeFrame: through surgery completion, an average of 16 weeks
Secondary outcomes:
measure: breast pCR
timeFrame: through surgery completion, an average of 16 weeks
measure: RCB 0/I rate
timeFrame: through surgery completion, an average of 16 weeks
measure: RCB class
timeFrame: through surgery completion, an average of 16 weeks
measure: Rate of lymph node negative
timeFrame: through surgery completion, an average of 16 weeks
measure: ORR by physical examination
timeFrame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
measure: ORR by MRI
timeFrame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
measure: CBR by physical examination
timeFrame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
measure: CBR by MRI
timeFrame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
measure: iDFS
timeFrame: 2year,3year,5year,8year,10year
measure: EFS
timeFrame: 2year,3year,5year,8year,10year
measure: DDFS
timeFrame: 2year,3year,5year,8year,10year
measure: OS
timeFrame: 2year,3year,5year,8year,10year
measure: Quality of Life
timeFrame: Through study completion，an average of 1 year
measure: Quality of Life
timeFrame: Through study completion，an average of 1 year
measure: Safety
timeFrame: Through study completion，an average of 1 year
measure: Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients
timeFrame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References: