NCT05075512 The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
| NCT ID | NCT05075512 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Breast Neoplasm Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2023-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2021-09-01 with a primary completion date of 2023-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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;
Contact & Investigator
Jian Huang
STUDY DIRECTOR
Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT05075512 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasm Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05075512 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05075512 currently recruiting?
Yes, NCT05075512 is actively recruiting participants. Contact the research team at wxiaojia0803@163.com for enrollment information.
Where is the NCT05075512 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05075512 clinical trial?
NCT05075512 is sponsored by Zhejiang Cancer Hospital. The principal investigator is Jian Huang at Zhejiang Cancer Hospital. The trial plans to enroll 40 participants.