Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer

NCT03786575 | Unknown

• 1 other identifier: NCC1787
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast cancer. The primary endpoints were progression-free survival (PFS), and the secondary endpoints included overall survival time (OS), adverse events (AE), and severe adverse events (SAE).

Conditions

Breast Neoplasm Female; Therapeutics; Mutation

Keywords

Breast Neoplasm; Next Generation Sequencing; Endocrine Therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first

  up to 36 months

Secondary Outcomes (2)

• Overall survival (OS)

  up to 60 months

• Adverse events (AEs)

  up to 36 months

Study Arms (1)

NGS detection group

EXPERIMENTAL

Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.

Diagnostic Test: Next Generation Sequencing (NGS) detection

Interventions

Next Generation Sequencing (NGS) detection DIAGNOSTIC_TEST

The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy

NGS detection group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years, female；
• Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients with advanced breast cancer；
• According to RECIST standard, lesions can be measured (primary lesion length \> 1.0 cm or lymph node diameter \> 1.5 cm)；
• Previous endocrine therapy resistance, preparation for second-or-above-line endocrine therapy；
• No visceral crisis；
• ECOG PS score: 0-2 points;
• Laboratory criteria:
• ① white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L.
• ② platelet (\>100 \*109/L); hemoglobin (\>10g/dL); serum creatinine (\<1.5 \*normal value) upper limit (ULN); aspartate aminotransferase (AST) (\<2.5 \*ULN); alanine aminotransferase (ALT) (\<2.5 \*ULN); total bilirubin (\<1.5 \*ULN); serum creatinine (\<1.5 \*ULN);
• the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

You may not qualify if:

• Pregnant or lactation woman
• With mental disease
• With severe infection or active gastrointestinal ulcers
• With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
• taking part or participating in other clinical trials within one month.

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fei Ma, Dr.

CONTACT

+86-13910217780; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Oncology Medicine

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: December 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: December 31, 2021
• Last Updated: June 20, 2019

Record last verified: 2018-11

Locations

CN (1)