The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer

NCT05075512 | Recruiting Phase 2

• 1 other identifier: 2021SQGH00743
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  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 Outcomes (4)

• Overall Response Rate

  From randomisation to the first occurrence of the confirmed complete response or partial response, assessed up to 24 months

• Clinical Benefit Rate

  From randomisation to the first occurrence of the confirmed complete response or partial response or stable disease, assessed up to 24 months

• Overall Survival

  From randomisation to death, assessed up to 96 months

• Adverse events

  From randomisation to 30 days after the last dose administrated

Study Arms (1)

experimental group

EXPERIMENTAL

anlotinib combined with fulvestrant

Drug: anlotinib, fulvestrant

Interventions

anlotinib, fulvestrant DRUG

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

Also known as: AL3818

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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;

You may not qualify 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;
• 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;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

anlotinib; Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jian Huang

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaojia Wang

CONTACT

+86 13906500190; wxiaojia0803@163.com

Jian Huang

CONTACT

+86 13588048995; huang_jian22@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: October 12, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2023
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: from the trial begin and for 10 years
• Access Criteria: every one

Locations

CN (1)