English Translation (Professional Medical Version) This study is a multicenter, prospective clinical trial designed to investigate the efficacy and safety of neoadjuvant therapy with trastuzumab plus pertuzumab combined with metronomic vinorelbine chemotherapy in elderly patients with HER2-positive breast cancer.
Eligible patients were aged ≥70 years, with histopathologically confirmed primary HER2-positive breast cancer, and met the indications for neoadjuvant therapy as stipulated in the clinical guidelines for the diagnosis and treatment of breast cancer.
A Simon two-stage design was employed in this study, with a planned total enrollment of 45 patients. In the first stage, 14 patients would be enrolled. If the number of observed responders was no more than 6, the trial would be terminated; otherwise, the trial would advance to the second stage, and the total sample size would be expanded to 45 patients.
The treatment regimen comprised 6 cycles of trastuzumab combined with pertuzumab (subcutaneous pertuzumab/trastuzumab fixed-dose combination was permitted as an alternative to intravenous formulations) plus metronomic vinorelbine therapy. Tumor response was assessed by imaging every 2 cycles. Patients with a confirmed response would complete all 6 cycles of treatment and undergo surgery per investigator assessment; postoperative pathological reports would be evaluated to determine the achievement of tpCR. For non-responders, the treatment regimen would be modified or surgery would be performed at the investigator's discretion.
Subjects voluntarily participate in this study and sign informed consent.
Age ≥70 years at the time of informed consent signing.
ECOG performance status (PS) 0-1; expected survival >3 months.
Primary HER2-positive breast cancer confirmed by histopathology or cytology.
Stage Ⅳ metastatic breast cancer, or patients who cannot undergo curative surgical resection after neoadjuvant therapy as assessed by investigators.
Prior anti-tumor therapies including chemotherapy, endocrine therapy, anti-HER2 biological therapy, or previous breast surgery (excluding diagnostic biopsy for primary breast cancer).
Other malignancies diagnosed within 3 years or concurrent malignant tumors at enrollment.
The following cases are eligible: Other malignancies treated solely by surgery with continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumors (Ta: non-invasive tumor, Tis: carcinoma in situ, T1: basement membrane-invasive tumor).
Single group
neoadjuvant therapy
Combination productVinorelbine soft capsules 40 mg, orally (PO), three times weekly (tiw) Trastuzumab: initial loading dose 8 mg/kg, maintenance dose 6 mg/kg, intravenous infusion, administered once every 3 weeks. Pertuzumab: initial loading dose 840 mg, maintenance dose 420 mg, intravenous infusion, administered once every 3 weeks. Each treatment cycle lasts 3 weeks. Imaging evaluations, including breast MRI, ultrasonography and computed tomography (CT), were performed every 2 cycles. For patients with tumor response, surgical indication was assessed after 6 cycles of treatment. Postoperative pathology was used to determine the pathological complete response (pCR) rate, and adjuvant treatment regimens were formulated according to postoperative pathological findings.
Total pathological complete response (tpCR)
It indicates that no residual invasive cancer cells are detected pathologically in both primary breast lesions and axillary lymph nodes after neoadjuvant therapy and surgical operation.
Event-free survival （EFS）
The time interval from study enrollment to the occurrence of any prognosis-impacting events, including local or distant recurrence, secondary primary malignancy, and all-cause death.
Objective response rate in patients undergoing neoadjuvant therapy （ORR）
The proportion of patients who achieve remarkable tumor shrinkage meeting the criteria of partial response or complete response.
Disease control rate（DCR）
The proportion of patients with clinically controlled tumors, including those with complete response, partial response and stable disease.
Invasive disease-free survival （iDFS）
The time from surgery to invasive breast cancer recurrence, non-breast second primary tumor, or death from any cause.
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