This is a phase II single-center single-arm clinical study designed to analyze the efficacy and safety of trastuzumab combined with taxane neoadjuvant therapy for HER2-positive breast carcinoma in situ (or with invasive carcinoma).
This Phase II single-center, single-arm clinical study was designed to evaluate the efficacy and safety of trastuzumab combined with taxane as a neoadjuvant treatment for patients with HER2-positive breast cancer in situ or invasive breast cancer. The study was designed to determine breast-conserving surgery rates and pathologic complete response (pCR) rates, assess tumor size reduction, and evaluate potential adverse events associated with treatment options. Participants will be treated with trastuzumab and taxane on a prescribed schedule, with periodic evaluations including imaging, histopathological analysis, and safety monitoring. The aim is to gain insight into the therapeutic potential of this combination therapy in improving outcomes for patients with HER2-positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Trastuzumab combined with taxane neoadjuvant therapy
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Breast-conserving surgery rate after 4-6 cycles of treatment
The breast-conserving surgery rate was calculated as a percentage of the total number of patients who successfully completed breast-conserving surgery after neoadjuvant therapy. For this study, all patients were required to confirm after treatment that the tumor was resectable and had no significant metastasis by imaging evaluation, such as breast ultrasound or MRI.
Time frame: From the start of neoadjuvant therapy to the completion of surgery (approximately 3-4 months after enrollment)
pathological Complete Response (pCR)
pCR refers to the situation in which a patient's carcinoma in situ tumor has completely disappeared through pathological examination after neoadjuvant therapy. Measurement Tool: Histopathological examination of surgical specimens.
Time frame: Within 3-4 months from enrollment, at the completion of neoadjuvant therapy.
Objective Response Rate (ORR)
ORR is the proportion of patients whose tumors have shrunk significantly over the course of treatment. Specifically, ORR includes both partial response (PR) and complete response (CR). Partial response (PR) : The maximum diameter or volume of the tumor is reduced by at least 30%, but it does not completely disappear. Complete response (CR) : The tumor disappears completely and no visible signs of cancer are confirmed by imaging tests, such as CT scans, MRI, or ultrasound. Measurement Tool: Imaging assessments (MRI, CT, or ultrasound).
Time frame: Within 3-4 months from enrollment, at the completion of neoadjuvant therapy.
Event-free survival (EFS) of 3 years
Event-free survival (EFS) is defined as the time from the initiation of neoadjuvant therapy to the first occurrence of disease progression, recurrence, second primary cancer, or death from any cause. In this study, 3-year EFS is defined as the proportion of patients who have not experienced any of these events within 36 months after starting treatment. Measurement Tool: Clinical and imaging follow-ups, verified by medical records.
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Time frame: At 36 months from the date of enrollment.
Event-free survival (EFS) of 5 years
Measurement Tool: Clinical and imaging follow-ups, verified by medical records.
Time frame: At 60 months from the date of enrollment.
Overall survival
Measurement Tool: Survival status verified through medical records and patient follow-up.
Time frame: From enrollment to 60 months ± 3 months or until the date of death from any cause, whichever occurs first.
Biomarker analysis o f HER2 and Ki-67 using immunohistochemistry (IHC) or quantitative PCR
Measurement Tool: Expression levels of specific biomarkers, such as HER2 and Ki-67, will be assessed using immunohistochemistry (IHC) or quantitative PCR, with tumor tissue or blood samples collected at baseline and post-therapy.
Time frame: Within 4-6 months from enrollment, at the completion of surgery.
AE rate
Adverse event rate
Time frame: From enrollment to 12 months after the end of study treatment.
Assessment of quality of life in patients using the FACT-B scale
Quality of life refers to people's perception and experience of their physical state, mental function, social ability, and overall personal situation based on socioeconomic, cultural background and value orientation. FACT-B scale was used to assess patients before treatment, during treatment (from the first day of the third cycle, and every two cycles thereafter), and 30 days after treatment. Patients' quality of life was quantified by the proportion of changes in the score
Time frame: From enrollment to 12 months after the end of study treatment or the last follow-up visit.