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

Overview

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.

Interventions

• Drug utidelone
  utidelone 50mg／m2，ivgtt，d1，8，15，22, q28d, up to 4 cycle；
• Drug Cisplatin
  cisplatin25mg/m2，ivgtt，d1，8，15；q28d, up to 4 cycle.
• Drug Trastuzumab
  Trastuzumab 8mg/kg, ivgtt, d1, then 6mg/kg, q21d or Trastuzumab 4mg/kg, ivgtt, d1, then 2mg/kg, q7d or Trastuzumab Injection（Subcutaneous Injection）600mg，subcutaneous Injection，d1，q21d
• Drug Pertuzumab
  Pertuzumab 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase

Primary outcome measures

• pCR [Time frame: through surgery completion, an average of 16 weeks]

Secondary outcome measures (12)

• breast pCR [Time frame: through surgery completion, an average of 16 weeks]
• RCB 0/I rate [Time frame: through surgery completion, an average of 16 weeks]
• RCB class [Time frame: through surgery completion, an average of 16 weeks]
• Rate of lymph node negative [Time frame: through surgery completion, an average of 16 weeks]
• ORR by physical examination [Time frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks]
• ORR by MRI [Time frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks]
• CBR by physical examination [Time frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks]
• CBR by MRI [Time frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks]
• iDFS [Time frame: 2year,3year,5year,8year,10year]
• EFS [Time frame: 2year,3year,5year,8year,10year]
• DDFS [Time frame: 2year,3year,5year,8year,10year]
• OS [Time frame: 2year,3year,5year,8year,10year]

Eligibility criteria

Inclusion criteria

• Age ≥18 years old;
• 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;
• According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;
• The score of ECOG is 0 or 1;
• During neoadjuvant therapy, ovarian function suppression can be given at the same time;
• 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;
• creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);
• Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.

Exclusion criteria

• 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;
• There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;
• There is evidence of sensory or motor nerve diseases;
• Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;
• allergic to the research drug or its auxiliary materials;
• 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;
• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
• Renji Hospital — Shanghai

Identifiers

NCT: NCT06510465 · SHPD009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗