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

Study acronym: ACNTBC
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Results first posted: Jun 10, 2026v2 Show 10 more changesShow less
    • Primary completion date changed from estimate of Jul 30, 2023 to Aug 15, 2024
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 31
    • Study completion date: Jul 30, 2025 to Jul 30, 2028
    • Start date changed from estimate of Nov 30, 2022 to Dec 5, 2022
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 2 to 5
    • Study description revised
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Xijing Hospital
179 trials monitored
See 8 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This study aims to evaluate the efficacy and safety of adding anlotinib to standard neoadjuvant chemotherapy in primary (HER2)-negative breast cancer. Patients aged 18 years or older with previously untreated stage Ⅱ-III histologically documented (HER2)-negative breast cancer were assigned to receive chemotherapy plus oral Anlotinib. The primary endpoint was pathologic complete response (pCR) (no invasive carcinoma in breast or axilla). Secondary end points included safety and event-free survival (EFS).
Trial Details
NCT Number NCT05558722
Lead Sponsor Xijing Hospital
Conditions
(from sponsor)		 Breast Cancer Stage II
Related terms Breast Neoplasms
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov