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

Primary Purpose

Breast Neoplasm Female, Therapeutics, Mutation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Next Generation Sequencing (NGS) detection
Sponsored by
Peking Union Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm Female focused on measuring Breast Neoplasm, Next Generation Sequencing, Endocrine Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 years, female；
  2. Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients with advanced breast cancer；
  3. According to RECIST standard, lesions can be measured (primary lesion length > 1.0 cm or lymph node diameter > 1.5 cm)；
  4. Previous endocrine therapy resistance, preparation for second-or-above-line endocrine therapy；
  5. No visceral crisis；
  6. ECOG PS score: 0-2 points;

  7. 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);

  8. the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NGS detection group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)
Time from first use endocrine treatment to death
Adverse events (AEs)
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)

Full Information

First Posted
December 21, 2018
Last Updated
June 19, 2019
Sponsor
Peking Union Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03786575
Brief Title
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
Official Title
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated treatment plan according to the test results: 1) those with ESR1 mutation and who did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3) those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If the efficacy evaluation is effective, continue the current treatment and re-evaluate the efficacy every two months; if the efficacy evaluation is ineffective (progress), then withdraw from this study. The vital signs, blood routine, liver and kidney functions and imaging examinations were examined at least every two months in the patients in the study group, and the curative effect was evaluated according to RECIST v1.1 standard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Therapeutics, Mutation
Keywords
Breast Neoplasm, Next Generation Sequencing, Endocrine Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NGS detection group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Next Generation Sequencing (NGS) detection
Intervention Description
The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Time from first use endocrine treatment to death
Time Frame
up to 60 months
Title
Adverse events (AEs)
Description
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
Time Frame
up to 36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Ma, Dr.
Phone
+86-13910217780
Email
drmafei@126.com
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Ma, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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