ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments

NCT04212702 | Unknown

• 1 other identifier: 201703138RIPD
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The percentage of ESR1 LBD mutation variant

  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 Outcomes (1)

• Progression-free Survival (PFS)

  12 months

Interventions

Hormonal therapy-based treatments DRUG

Hormonal therapy-based treatments, ex. HT single agent, HT plus other targeted therapy, HT plus everolimus, HT plus metronomic oral chemotherapy or oral chemotherapy only

Also known as: HT single agent, HT plus other targeted therapy, HT plus everolimus, HT plus metronomic oral chemotherapy or oral chemotherapy only

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asian ER positive/HER2 negative metastatic breast cancer

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Novartis: collaborator

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 8 ml plasma sample will be prepared from 20 ml whole blood to be used for circulating cell free DNA (cfDNA) extraction using the QIAamp Circulating Nucleic Acid Kit (Qiagen, Hilden, Germany, Cat. No. 55114). DNA concentration will be determined by the Qubit fluorometer (Thermo Fisher Scientific, Wilmington, DE, USA) and DNA integrity will be analyzed using the capillary electrophoresis (AATI Fragment analyzer).

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Yen-Shen Lu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 27, 2019
• Study Start: May 22, 2017
• Primary Completion: February 1, 2020
• Study Completion: December 31, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

TW (2)