- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05075512
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
October 10, 2021 updated by: Zhejiang Cancer Hospital
A Prospective Study on Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With HR-positive and HER2-negative, Secondary Endocrine-resistant, Locally Advanced or Metastatic Breast Cancer
The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops.
Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality.
Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET.
Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer.
This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, single-arm, open-label, phase II clinical trial.
The secondary endocrine-resistant is defined as disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy.
Eligible patients were treated with oral anlotinib plus intramuscular fulvestrant till disease progression or intolerant toxicity.
In the part of statistical analysis, 40 patients are required to have a 80% power to detect significant improvement in median progression-free survival from 5.8 (fulvestrant alone) to 10 (fulvestrant combined with anlotinib) months, if tested at a two-sided significance level of α=0.05.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaojia Wang
- Phone Number: +86 13906500190
- Email: wxiaojia0803@163.com
Study Contact Backup
- Name: Jian Huang
- Phone Number: +86 13588048995
- Email: huang_jian22@aliyun.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Xiaojia Wang
- Phone Number: +86 13906500190
- Email: wxiaojia0803@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged 18 years or older female;
- ECOG score 0-1;
- Life expectancy is not less than 12 weeks;
- Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;
- Premenopausal women have taken effective ovarian function suppression methods, such as drug suppression or ovariectomy;
- At least one objectively measurable breast cancer lesions according to RECIST 1.1 ;
- No more than one systemic chemotherapy for metastatic disease;
- Disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy;
- Normal function of main organs and bone marrow: Hemoglobin≥90g/L; Neutrophil count (ANC)≥1.5×109/L; Platelet count (PLT)≥80×109/L; Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤5×ULN if has liver metastasis); Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60mL/min (Cockcroft-Gault formula);
- Sign the informed consent;
Exclusion Criteria:
- Have received prior fulvestrant or anti-angiogenic drug treatment, or known to be allergic to any excipients in the study;
- Visceral crisis;
- Uncontrolled or high-burden CNS metastases;
- Unable to swallow;
- Abnormal coagulation function;
- Tumor has invaded important blood vessels and may cause fatal bleeding;
- Pleural effusion or pericardial effusion that requiring repeated drainage;
- Hypertension that cannot be well controlled by a single antihypertensive drug;
- Unstable angina, myocardial infarction within 6 months, serious arrhythmias;
- The history of immunodeficiency, including HIV or other obtained or congenital immunodeficiency diseases, or a history of organ transplantation;
- Poorly controlled diabetes;
- Abnormal urine protein, and the 24-hour quantification suggests urine protein ≥1.0g;
- Bleeding constitution or medical history
- Unhealed wounds, ulcers or fractures;
- Have arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- In other clinical trials of anti-tumor drugs simultaneously;
- Other concomitant disease or disability that endangers safety according to the judgment of investigator;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
anlotinib combined with fulvestrant
|
anlotinib: 12 mg once daily on days 1-14, repeated every 21 days; fulvestrant: 500 mg on days 1 and 15 of cycle one, and then on day one of each subsequent 28 days cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival
Time Frame: From randomisation to progression or death, assessed up to 60 months
|
Time from randomisation to tumour progression (in any way) or death (from any cause)
|
From randomisation to progression or death, assessed up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: From randomisation to the first occurrence of the confirmed complete response or partial response, assessed up to 24 months
|
Confirmed complete response or partial response according to RECIST 1.1
|
From randomisation to the first occurrence of the confirmed complete response or partial response, assessed up to 24 months
|
Clinical Benefit Rate
Time Frame: From randomisation to the first occurrence of the confirmed complete response or partial response or stable disease, assessed up to 24 months
|
Confirmed complete response or partial response or stable disease of 24 weeks' duration or longer
|
From randomisation to the first occurrence of the confirmed complete response or partial response or stable disease, assessed up to 24 months
|
Overall Survival
Time Frame: From randomisation to death, assessed up to 96 months
|
Time from randomisation to death (from any cause)
|
From randomisation to death, assessed up to 96 months
|
Adverse events
Time Frame: From randomisation to 30 days after the last dose administrated
|
Adverse events occurred from randomisation to 30 days after the last dose administrated
|
From randomisation to 30 days after the last dose administrated
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jian Huang, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Anticipated)
August 31, 2023
Study Completion (Anticipated)
August 31, 2026
Study Registration Dates
First Submitted
August 9, 2021
First Submitted That Met QC Criteria
October 10, 2021
First Posted (Actual)
October 12, 2021
Study Record Updates
Last Update Posted (Actual)
October 12, 2021
Last Update Submitted That Met QC Criteria
October 10, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021SQGH00743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
the data will be shared from the trial begin and for 10 years
IPD Sharing Time Frame
from the trial begin and for 10 years
IPD Sharing Access Criteria
every one
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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