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

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05558722
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
32
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 ⅡB-IIIA 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 disease-free survival (DFS).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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 phase II 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 ⅡB-IIIA histologically documented (HER2)-negative breast cancer were assigned to receive chemotherapy plus oral Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles). Chemotherapy comprised of pirarubicin at 50 mg/m2 and cyclophosphamide at 500 mg/m2 and albumin-bound paclitaxel at 200 mg/m2, (d1, 21 days per cycle; both total 6 cycles), which was then followed by surgery. The primary endpoint was pathologic complete response (pCR) (no invasive carcinoma in breast or axilla). Secondary end points included safety and disease-free survival (DFS). Stratification was based on the clinical breast cancer stage .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Assigned to receive chemotherapy plus oral Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles)，chemotherapy comprised of pirarubicin at 50 mg/m2 and cyclophosphamide at 500 mg/m2 and albumin-bound paclitaxel at 200 mg/m2, (d1, 21 days per cycle; both total 6 cycles), which was then followed by surgery.Assigned to receive chemotherapy plus oral Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles)，chemotherapy comprised of pirarubicin at 50 mg/m2 and cyclophosphamide at 500 mg/m2 and albumin-bound paclitaxel at 200 mg/m2, (d1, 21 days per cycle; both total 6 cycles), which was then followed by surgery.
Masking:
None (Open Label)
Masking Description:
Check all roles that are masked or check None.
Primary Purpose:
Treatment
Official Title:
Anlotinib Plus Chemotherapy as Neoadjuvant Treatment of High-risk, Early-stage Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer: A Prospective, Single-arm, Single-center, Phase II Clinical Study
Anticipated Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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);
Other Names:
  • TAC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pCR( pathological complete remission) [8 weeks]

      Pathological complete remission rate assessed by the investigator

    Secondary Outcome Measures

    1. ADR [8 weeks]

      Adverse Drug Reactions

    2. DFS [8 weeks]

      DFS(Disease-free survival)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients were HER2 negative, defi ned as munohistochemistry of 0/1+, or if 2+, fl uorescence insitu hybridisation showed no evidence of amplifi cation of the HER2 gene.

    • Patients were required to have a palpable primary tumor at least 2.0 cm in diameter in the breast, as assessed by physical examination, and to be classified as having tumor stage T1c to T3, nodal stage N0 to N2a, and metastasis stage M0.

    • Other eligibility criteria adequate cardiac function (left ventricular ejection fraction within the normal institutional range, as assessed by multiplegated acquisition scan or echocardiogram), adequate bone marrow, hepatic, and renal function, and appropriate Eastern Cooperative Oncology Group (ECOG) performance status (0-2).

    • All patients provided written informed consent.

    Exclusion Criteria:

    • Previously received anti-angiogenesis targeted drug therapy.

    • patients have previous diagnosis of ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, gastroduodenal ulcer, symptomatic diverticulitis, or inflammatory bowel disease.

    • Previously received chemotherapy, radiotherapy, or endocrine therapy as treatment for breast cancer was allowed.

    • No uncont rolled hypertension.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hospital Affiliated to Air Force Military Medical University Xi'an Shannxi Province China 710032

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    • Principal Investigator: Ting Wang, PhD, Xijing Hospital Affiliated to Air Force Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT05558722
    Other Study ID Numbers:
    • KY20202075-F-2
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Sep 28, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xijing Hospital
    Breast cancer Antivascular drugs Neoadjuvant therapy
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Sep 28, 2022