Combination of Fulvestrant and Anlotinib for Breast Cancer with FGFR Mutation

A Phase II Study of the Efficacy and Tolerability of Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer Patients With FGFR Mutation

This study is testing if combining two drugs, fulvestrant and anlotinib, can help women with a specific type of breast cancer that hasn't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Anlotinib, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04936295 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining fulvestrant with anlotinib in women with HR+/HER2- metastatic breast cancer who have FGFR mutations and have shown resistance to aromatase inhibitor therapy. The study aims to address the challenge of endocrine therapy resistance by targeting the FGF signaling pathway, which is implicated in this resistance. It is a single-arm, single-center phase II trial conducted at Sun Yat-sen University Cancer Center, focusing on patients who have experienced disease progression. The goal is to provide new treatment options for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-75 with HR+/HER2- metastatic breast cancer, FGFR mutations, and prior treatment failure with aromatase inhibitors.

Not a fit: Patients with HER2-positive breast cancer or those without FGFR mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with resistant metastatic breast cancer, potentially improving their outcomes.

How similar studies have performed: While there is limited evidence on the combination of endocrine therapy and FGFR inhibitors, previous studies have shown promise in targeting the FGF signaling pathway in breast cancer.

Eligibility 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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Fei Xu, MD — Sun Yat-sen University
• Study coordinator: Fei Xu, MD

Conditions Breast Cancer