Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation

NCT04936295 | Unknown Phase 2

• 1 other identifier: SYSU005
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have shown that the FGF signaling pathway is closely related to endocrine therapy resistance in breast cancer, but there is not sufficient evidence for the combination of endocrine therapy and FGFR inhibitors. Anlotinib is a highly effective VEGFRs, FGFRs, PDGFRs multi-target tyrosine kinase inhibitor. Therefore, we conducted this single-arm, single-center phase II clinical study to evaluate the efficacy and the safety of anlotinib combined with fulvestrant in patients with metastatic HR+/HER2- breast cancer patients with FGFR mutation and resistance to aromatase inhibitor therapy, to provide new treatment options for these patients.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate (CBR)

  Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 3 months till progression or termination of the study. CBR is defined as ratio of participants who have stable disease for over 24 weeks.

  24 weeks

Secondary Outcomes (5)

• Progression free survival (PFS)

  1 year

• Objective response rate (ORR)

  1 year

• Overall survival (OS)

  3 years

• Number of Participants with Adverse Events

  1 year

• The quality of life

  1 year

Study Arms (1)

Fulvestrant plus Anlotinib

EXPERIMENTAL

Each participant receives fulvestrant combined with anlotinib.

Drug: Fulvestrant plus Anlotinib

Interventions

Fulvestrant plus Anlotinib DRUG

Each patient receives Fulvestrant (500mg delivered by intramuscular injection every 4 weeks) plus Anlotinib(20mg taken orally for 14 days and stop for 7 days in one cycle)

Fulvestrant plus Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form;
• years old;
• Women in any menstrual state, premenopausal or perimenopausal patients need to receive luteinizing hormone releasing hormone(LHRH) analogue;
• Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points;
• The expected survival period is ≥12 weeks;
• The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as \>1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection no amplification);
• Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor treatment failure;
• In the state of disease progression before enrollment;
• There are FGFR mutations, which meets any of the following: ①Immunohistochemical method: any subtype of FGFR1/2/3/4 is positive; ② Gene detection results of tissue/blood sample shows that any subtype of FGFR1/2/3/4 has functional variation such as amplification, activating mutation or fusion;
• Measurable disease according to RECIST version 1.1 or only bone metastasis;
• Adequate hematological, hepatic function;
• Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥50%.

You may not qualify if:

• Have used Fulvestrant or its analogues;
• History of other primary malignancy;
• Allergic to the ingredients of Anlotinib Hydrochloride Capsules;
• Previously received targeted drug therapy for FGFR;
• Received chemotherapy within 4 weeks before enrollment;
• Received endocrine therapy within 2 weeks before enrollment;
• Patients with currently symptomatic brain or meningeal metastasis;
• Concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study;
• Patients who cannot accept drugs orally;
• Any other situation that the investigator judges cannot be enrolled in the study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; anlotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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

• Fei Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Xu, MD

CONTACT

+86-13711277870; xufei@sysucc.org.cn

Kuikui Jiang, MD

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 23, 2021
• Study Start: June 16, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2025
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)