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Trial Title:
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
NCT ID:
NCT05558722
Condition:
Breast Cancer Stage II
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer Antivascular drugs Neoadjuvant therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Check all roles that are masked or check None.
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib
Description:
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);
Arm group label:
Anlotinib
Other name:
TAC
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).
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 .
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hospital Affiliated to Air Force Military Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Wang, PhD
Phone:
0086-13700283101
Email:
ting_w100@126.com
Start date:
November 30, 2022
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558722
