- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936295
Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation
June 16, 2021 updated by: Xu fei, Sun Yat-sen University
A Phase II Study of the Efficacy and Tolerability of Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer Patients With FGFR Mutation
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Endocrine therapy resistance is an unsolved problem in the treatment of HR+/HER2- metastatic breast cancer.
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, which can effectively block the migration and proliferation of endothelial cells and reduce tumor microvessel density.
The drug inhibits VEGFRs, FGFRs, PDGFRs to exert anti-angiogenesis effects and to achieve anti-tumor effects.
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-positive and HER2-negative breast cancer patients with FGFR mutation and resistance to aromatase inhibitor therapy, to provide new treatment options for these patients.
Study Type
Interventional
Enrollment (Anticipated)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fei Xu, MD
- Phone Number: +86-13711277870
- Email: xufei@sysucc.org.cn
Study Contact Backup
- Name: Kuikui Jiang, MD
- Phone Number: +86-15210589011
- Email: jiangkk@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Fei Xu, MD
- Phone Number: +86-13711277870
- Email: xufei@sysucc.org.cn
-
Principal Investigator:
- Fei Xu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Voluntarily sign the informed consent form;
- 18-75 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%.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fulvestrant plus Anlotinib
Each participant receives fulvestrant combined with anlotinib.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical benefit rate (CBR)
Time Frame: 24 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The quality of life
Time Frame: 1 year
|
Using EORTC (European Organization for Research and Treatment of Cancer) QLQ-BR23 scale.
The minimum and maximum values are 0 and 100, respectively.
Higher scores mean better outcome.
|
1 year
|
Objective response rate (ORR)
Time Frame: 1 year
|
The proportion of best overall response of either complete or partial response.
|
1 year
|
Overall survival (OS)
Time Frame: 3 years
|
Time from the date of treatment to the date of death.
|
3 years
|
Number of Participants with Adverse Events
Time Frame: 1 year
|
Number of participants with adverse events related to the treatment.
|
1 year
|
Progression free survival (PFS)
Time Frame: 1 year
|
Time from the date of treatment to the date of tumor progression
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 16, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2025
Study Registration Dates
First Submitted
June 16, 2021
First Submitted That Met QC Criteria
June 16, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 16, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSU005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on Fulvestrant plus Anlotinib
-
Hunan Cancer HospitalFuzhou Pulmonary Hospital of Fujian; Chia Tai Tianqing Pharmaceutical Group...RecruitingSmall Cell Lung CancerChina
-
Hunan Cancer HospitalHenan Cancer Hospital; Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingNon Small Cell Lung CancerChina
-
Shanghai Changzheng HospitalCompletedColorectal Cancer | Immunotherapy | Sintilimab | First-line Treatment | Anlotinib | Chemo-free TherapyChina
-
Sun Yat-sen UniversityNot yet recruitingNon Clear Cell Renal CarcinomaChina
-
Shanghai Changzheng HospitalUnknownGastric Cancer | Immunotherapy | Anlotinib | Toripalimab | Gastro-oesophageal Junction CancerChina
-
Tianjin Medical University Cancer Institute and...Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedNon Small Cell Lung CancerChina
-
Peking Union Medical College HospitalRecruitingAnlotinib | Anti-PD-1 Antibody | Advanced Pancreatic CancerChina
-
Peking Union Medical College HospitalNot yet recruitingAnlotinib | Advanced Esophageal Squamous Cell Cancer | SHR-1210
-
Tianjin Medical University Cancer Institute and...RecruitingSmall Cell Lung Cancer Limited StageChina
-
The First People's Hospital of LianyungangChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownLung Neoplasms | Anlotinib | Docetaxel | S-1 | PemetrexedChina