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

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Breast cancer Antivascular drugs Neoadjuvant therapy

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 31 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Study arms

• Experimental
  Anlotinib

  Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles) Combined TAC×6 cycles.

  Drug: Anlotinib

Interventions

• DrugAnlotinib

  Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles) Combined TAC×6 cycles: albumin-bound paclitaxel (200mg/m2, 1d Q3W) + pirarubicin （50mg/m2, 1d Q3W) + cyclophosphamide (500mg/m2, 1d Q3W);

  Also known as: TAC

Primary outcomes

1. Pathological Complete Response (pCR) Rate

   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.

   Time frame: At definitive surgery, performed after completion of 6 cycles of neoadjuvant systemic therapy (approximately 18-24 weeks from treatment initiation).

Secondary outcomes

1. RCB 0/I Rate

   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.

   Time frame: At definitive surgery, performed after completion of 6 cycles of neoadjuvant systemic therapy (approximately 18-24 weeks from treatment initiation).

2. Number of Participants With Treatment-Related Adverse Events (TRAEs)

   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.

   Time frame: From first dose of study treatment through completion of neoadjuvant therapy and postoperative assessment, up to approximately 24-30 weeks per participant

3. EFS

   EFS(Event-free survival)

   Time frame: Long-term follow-up schedule for disease status and survival entailed evaluations every 3 months in the first 2 years after surgery, every 6 months for the subsequent three years, and then annually thereafter until the 10th year.

4. bpCR Rate

   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.

   Time frame: At definitive surgery, performed after completion of 6 cycles of neoadjuvant systemic therapy (approximately 18-24 weeks from treatment initiation).

5. apCR Rate

   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.

   Time frame: At definitive surgery, performed after completion of 6 cycles of neoadjuvant systemic therapy (approximately 18-24 weeks from treatment initiation).

Baseline characteristics

Study documents

• Study protocol · Apr 2, 2021
• Statistical analysis plan · Apr 2, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided