Trial Outcomes & Findings for Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer (NCT NCT05558722)

After providing informed consent, patients underwent baseline assessments including physical examination, breast MRI, core needle biopsy for histological confirmation, and immunohistochemistry staining for ER, PR, HER2, and Ki-67. Eligibility was confirmed based on theinclusion and exclusion criteria. Patients who met all inclusion criteria and none of the exclusion criteria were enrolled and assigned to receive study treatment.

Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer

Pathological complete response (pCR),which was also identified as total pCR (tpCR), was defined as the absence of invasive cancer in breast and no metastasis to regional lymph nodes (ypT0/is ypN0) in the surgical specimen after completion of neoadjuvant therapy, corresponding to Residual Cancer Burden (RCB) score of 0. Pathological response was evaluated by an independent pathologist blinded to treatment assignment on the resected breast specimen and axillary lymph nodes using H\&E staining. The RCB grading system was used as the primary method to quantify residual disease. RCB I indicates minimal residual disease. RCB II indicates moderate residual disease. RCB III indicates extensive residual disease (worst outcome). Lower RCB scores represent better pathological response and are associated with improved long-term survival outcomes. tpCR was considered the most stringent and clinically meaningful endpoint for neoadjuvant studies, representing complete eradication of invasive tumor.

The outcome measure is defined as the proportion of participants who achieve a Residual Cancer Burden (RCB) class of 0 or I following neoadjuvant therapy and surgical resection. RCB score is calculated using the standardized RCB calculator. Pathological evaluation is performed on surgical specimens according to institutional or central laboratory guidelines. RCB 0: Pathologic complete response (pCR), defined as no residual invasive carcinoma in the breast primary tumor and ipsilateral axillary lymph nodes (in situ carcinoma allowed). RCB I: Minimal residual tumor burden, indicating extensive tumor regression with only minor residual disease.

For safety evaluation, the severity grade (according to National Cancer Institute Common Terminology Criteria for Adverse Events, v 5.0) and the relationship to study treatment of AEs were assessed by physical examination and laboratory tests before and after every cycle, during follow-up visits, and upon indication by symptoms.

EFS(Event-free survival)

The outcome measure is defined as the proportion of participants who achieve breast pathologic complete response (bpCR) following neoadjuvant therapy and surgical resection. bpCR is defined as no residual invasive carcinoma in the breast primary tumor (residual ductal carcinoma in situ \[DCIS\] is allowed), regardless of axillary lymph node status.

The outcome measure is defined as the proportion of participants who achieve axillary pathologic complete response (apCR) following neoadjuvant therapy and surgical resection. apCR is defined as no residual invasive carcinoma in the ipsilateral axillary lymph nodes, regardless of breast primary tumor status.