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Tests treatment safety and results for Breast Neoplasm Female
Official title The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
ClinicalTrials.gov ID: NCT05075512
What this study is testing
What is anlotinib, fulvestrant?
anlotinib, fulvestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast neoplasm female.
Also referred to as AL3818.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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...
- Sign the informed consent;
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.