Breast Cancer
Conditions
Keywords
breast cancer, utidelone, cisplatin, neoadjuvant therapy
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.
Interventions
DRUGutidelone
utidelone 50mg／m2，ivgtt，d1，8，15，22, q28d, up to 4 cycle；
DRUGCisplatin
cisplatin25mg/m2，ivgtt，d1，8，15；q28d, up to 4 cycle.
DRUGTrastuzumab
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
DRUGPertuzumab
Pertuzumab 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase
Sponsors
RenJi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | through surgery completion, an average of 16 weeks | ypT0/is ypN0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RCB 0/I rate | through surgery completion, an average of 16 weeks | ratio of patients who achieved RCB 0 or RCB I |
| RCB class | through surgery completion, an average of 16 weeks | RCB 0, RCB I, RCB II, RCB III |
| Rate of lymph node negative | through surgery completion, an average of 16 weeks | ratio of patients who achieved lymph node negative |
| ORR by physical examination | After completing neoadjuvant therapy before surgery, an average of 16 weeks | ratio of patients who achieved complete response or partial response by physical examination |
| ORR by MRI | After completing neoadjuvant therapy before surgery, an average of 16 weeks | ratio of patients who achieved complete response or partial response by MRI |
| CBR by physical examination | After completing neoadjuvant therapy before surgery, an average of 16 weeks | ratio of patients who achieved complete response or partial response or stable disease by physical examination |
| CBR by MRI | After completing neoadjuvant therapy before surgery, an average of 16 weeks | ratio of patients who achieved complete response or partial response or stable disease by MRI |
| breast pCR | through surgery completion, an average of 16 weeks | ypT0/is |
| EFS | 2year,3year,5year,8year,10year | It is defined as the time from first dose of study intervention administration to the first occurrence of local and/or regional recurrence, contralateral breast cancer, distant metastasis or death from any cause. |
| DDFS | 2year,3year,5year,8year,10year | It is defined as the time from first dose of study intervention administration to the first distant metastasis or death from any cause. |
| OS | 2year,3year,5year,8year,10year | It is defined as the time from first dose of study intervention administration to death from any cause. |
| Quality of Life | Through study completion，an average of 1 year | EORTC-QLQ-C30 |
| Safety | Through study completion，an average of 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients | After completing neoadjuvant therapy before surgery, an average of 16 weeks | Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients |
| iDFS | 2year,3year,5year,8year,10year | It is defined as the time from first dose of study intervention administration to the first occurrence of ipsilateral invasive cancer recurrence, contralateral invasive breast cancer, local and/or regional invasive cancer recurrence, distant metastasis or death from any cause. |
Countries
China
Outcome results
None listed