The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced Breast Cancer.
This is a single arm, multi-center study,three-cohort, prospective phase II study which will enroll 181 high-risk early-stage or locally advanced breast cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
181
Utidelone injection 30mg/m2, on days 1-5 of each cycle
Carboplatin Area under curve(AUC)6, iv, was administered on day 1
Epirubicin 75mg/m2 was administered on day 1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Total pathological complete response (etpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is, (yp)N0)
Percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and breast
Time frame: 24 months
Breast Pathologic Complete Response ((bpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is)
Percentage of patients whose pathological evaluation of hematoxylin and eosin-stained breast samples do not show any residual invasive carcinoma
Time frame: 24 months
Event Free Survival(EFS) of 2 years
Time from the first dose of study intervention administration to any of the following events: progression of disease that precludes surgery, local or distant recurrence after surgery, second primary malignancy (breast or other invasive cancers), or death due to any cause.
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Graded according to the Common Terminology Criteria for Adverse Event (CTCAE) grade and changes in CTCAE grade
Time frame: Through study completion,an average of 1 year
Patient reported outcome (PRO)
National Cancer Center of China-Breast Cancer-A 1.0 (NCC-BC-A 1.0) during the study was used to assess the quality of life;The minimum to maximum values: 0 , 100 Meaning: the higher scores mean a better outcome.
Time frame: Through study completion,an average of 1 year
Patient reported outcome (PRO)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-chemotherapy-induced peripheral neuropathy(CIPN) twenty-item scale (QLQ-CIPN20) was used to assess the quality of life.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles
Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles
Time frame: Through study completion,an average of 1 year