Overview

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

Status:
Recruiting

Trial end date:
2025-06-01

Target enrollment:
0

Participant gender:
Female

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sun Yat-sen University

Treatments:

Fulvestrant

Criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form;

2. 18-75 years old;

3. Women in any menstrual state, premenopausal or perimenopausal patients need to receive
luteinizing hormone releasing hormone(LHRH) analogue;

4. Eastern Cooperative Oncology Group (ECOG) score [0-1] points;

5. The expected survival period is ≥12 weeks;

6. 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);

7. Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor
treatment failure;

8. In the state of disease progression before enrollment;

9. 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;

10. Measurable disease according to RECIST version 1.1 or only bone metastasis;

11. Adequate hematological, hepatic function;

12. Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥50%.

Exclusion Criteria:

1. Have used Fulvestrant or its analogues;

2. History of other primary malignancy;

3. Allergic to the ingredients of Anlotinib Hydrochloride Capsules;

4. Previously received targeted drug therapy for FGFR;

5. Received chemotherapy within 4 weeks before enrollment;

6. Received endocrine therapy within 2 weeks before enrollment;

7. Patients with currently symptomatic brain or meningeal metastasis;

8. 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;

9. Patients who cannot accept drugs orally;

10. Any other situation that the investigator judges cannot be enrolled in the study.