- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212702
ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments
January 11, 2021 updated by: National Taiwan University Hospital
The Landscape of ESR1 Mutations in Asian Estrogen Receptor-positive Metastatic Breast Cancer Patients Detected by Liquid Biopsy and Impact on Hormonal Therapy-based Treatments
The investigator propose a prospective study using blood samples (liquid biopsy) of estrogen receptor (ER)-positive metastatic breast cancer (MBC) patients to understand the prevalence of estrogen receptor 1 (ESR1) mutation variants and the correlation with hormonal therapy (HT)-based treatment resistance in Asian ER-positive/human epidermal growth receptor-2 (HER2)-negative MBC population.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The investigator will use next-generation targeted sequencing covering the entire ESR1 ligand-binding domain (LBD) region to understand 1. the spectrum and prevalence of specific ESR1 mutation variants in Asian women, and 2. the preliminary correlation of Asian-specific prevalent ESR1 LBD mutation variants such as Y537C with treatment efficacy.
For the second purpose, the investigator will specifically focus on patients with ESR1 Y537C mutation, while the results from patients with wild type ESR1 and patients with D538G or Y537S mutant will be severed as control for preliminary comparison.
Study Type
Observational
Enrollment (Actual)
123
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Taipei, Taiwan, 114
- Tri-Service General Hospital
-
-
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Asian ER positive/HER2 negative metastatic breast cancer
Description
Inclusion Criteria:
- (1) Female patients who are ≥ 20 years old at the time of informed consent.
- (2) Have histologically confirmed ER positive (defined as ≥1%) and/ or progesterone receptor (PR) positive (defined as ≥1%) breast cancer.
- (3) Have histologically confirmed HER2-negative breast cancer as defined by immuno-histochemistry (IHC) ≤ 2+, and/or fluorescence in situ hybridization (FISH) negative.
- (4) Patients who fits either one of the following two criteria are eligible: I. Have radiological or objective evidence of inoperable locally advanced or metastatic breast cancer and are planned to be given HT single agent, HT plus other targeted therapy, HT plus everolimus (reimbursed by National Health Insurance), HT plus metronomic oral chemotherapy or oral chemotherapy only by the treating physician. II. Locally advanced but operable patients before the resection of the primary tumor.
Exclusion Criteria:
- (1) Patients not suitable for oral anti-cancer treatment as determined by the investigator.
- (2) Known hypersensitivity to mammilian target of rapamycin (mTOR) inhibitors, e.g. Sirolimus (rapamycin).
- (3) Patients with a known history of HIV seropositivity. Screening for HIV infection at baseline is not required.
- (4) Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of ESR1 LBD mutation variant
Time Frame: 12 months
|
The percentage of each ESR1 LBD mutation variant in Asian ER-positive/HER2-negative MBC who had received at least one line of HT
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: 12 months
|
PFS of patients who are treated with everolimus plus HT with either ESR1 wild type or different Asian-specific prevalent ESR1 LBD mutation variants such as Y537C
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yen-Shen Lu, MD, PhD, National Taiwan University Hospital
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 (Actual)
May 22, 2017
Primary Completion (Actual)
February 1, 2020
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
December 25, 2019
First Submitted That Met QC Criteria
December 25, 2019
First Posted (Actual)
December 27, 2019
Study Record Updates
Last Update Posted (Actual)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201703138RIPD
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 Metastatic Breast Cancer
-
Gilead SciencesRecruitingStudy of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors (ASCENT-J02)Advanced Solid Tumor | Metastatic Urothelial Cancer | Metastatic Triple-Negative Breast Cancer | HR+/HER2- Metastatic Breast CancerJapan
-
BriaCell Therapeutics CorporationRecruitingBreast Cancer | Breast Neoplasm | Metastatic Breast Cancer | Breast Cancer Metastatic | End Stage CancerUnited States
-
OBI Pharma, IncCompletedMetastatic Colorectal Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Gastric CancerTaiwan
-
GlycoMimetics IncorporatedTerminatedBreast Cancer | Breast Cancer Metastatic | HR+ Metastatic Breast CancerUnited States
-
Massachusetts General HospitalPuma Biotechnology, Inc.; Celcuity, Inc.WithdrawnMetastatic Breast Cancer | Invasive Breast Cancer | HER2-negative Breast Cancer | ER Positive Breast Cancer | PR-Positive Breast Cancer | Stage IV (Metastatic) Breast CancerUnited States
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyCompletedMetastatic Breast Cancer | Metastatic Triple Negative Breast CancerJapan, Belgium, France, Netherlands
-
Novartis PharmaceuticalsCompletedMetastatic Breast Cancer | Postmenopausal Women | Locally Advanced Metastatic Breast CancerIsrael
-
BriaCell Therapeutics CorporationLumaBridgeEnrolling by invitationBreast Cancer | Breast Neoplasm | Metastatic Breast Cancer | Breast Cancer MetastaticUnited States
-
Prof. Wolfgang JanniEli Lilly and CompanyRecruitingHormone Receptor-positive Metastatic Breast Cancer | HER2-negative Metastatic Breast CancerGermany, Switzerland
-
National Cancer Institute, EgyptRecruitingBreast Cancer | Metastatic Cancer | Metastatic Breast CancerEgypt
Clinical Trials on Hormonal therapy-based treatments
-
Waldfriede HospitalActive, not recruiting
-
Icahn School of Medicine at Mount SinaiAlbert Einstein College of Medicine; The Institute for Family Health; Maryland...CompletedChronic Low Back Pain | Chronic Neck Pain | Osteoarthritis PainUnited States
-
Mayo ClinicCompleted
-
Universidad Europea de MadridCompletedDepression | Quality of Life | Sleep | Anxiety | Self Efficacy | Central Sensitisation | Kinesiophobia | CatastrophizingSpain
-
University of RzeszowCompletedRehabilitation | Neurological Diseases | BiofeedbackPoland
-
National Multiple Sclerosis SocietyUnknown
-
Judge Baker Children's CenterUniversity of Illinois at Chicago; University of Hawaii; MacArthur FoundationCompleted
-
University of AlbertaCapital Health, CanadaCompletedPneumonia | Diabetes Mellitus, Type 2 | Pulmonary Disease, Chronic Obstructive | Coronary Arteriosclerosis | Heart Failure, CongestiveCanada
-
Air Force Military Medical University, ChinaUnknownCritically Ill | HypernatremiaChina