Combining Anlotinib and Fulvestrant for Advanced Breast Cancer

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

This study is testing if combining two medications, anlotinib and fulvestrant, can help women with advanced breast cancer who haven't responded to other treatments live longer without their cancer getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Anlotinib
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05075512 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of anlotinib, a multi-target tyrosine kinase inhibitor, combined with fulvestrant in women with advanced HR-positive, HER2-negative breast cancer. The study aims to treat patients who have shown resistance to endocrine therapy by administering these two medications until disease progression or intolerable toxicity occurs. A total of 40 patients will be enrolled to assess whether this combination can significantly improve progression-free survival compared to fulvestrant alone.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 18 or older with HR-positive, HER2-negative advanced breast cancer who have experienced disease relapse after prior endocrine therapy.

Not a fit: Patients who are not HR-positive or HER2-negative, or those who have not undergone prior endocrine therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced breast cancer who have developed resistance to standard endocrine therapies.

How similar studies have performed: Previous studies have shown promising results with both anlotinib and fulvestrant in advanced breast cancer, indicating that this combination approach is a logical next step.

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;

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaojia Wang

Conditions Breast Neoplasm Female