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

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ClinicalTrials.gov Identifier: NCT03786575
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Fei Ma, Peking Union Medical College

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).

Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Therapeutics Mutation Diagnostic Test: Next Generation Sequencing (NGS) detection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NGS detection group
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
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 Measures :
  1. Progression-free survival (PFS) [ Time Frame: up to 36 months ]
    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 :
  1. Overall survival (OS) [ Time Frame: up to 60 months ]
    Time from first use endocrine treatment to death

  2. Adverse events (AEs) [ Time Frame: up to 36 months ]
    Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786575


Contacts
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Contact: Fei Ma, Dr. +86-13910217780 drmafei@126.com

Locations
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China
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, China
Contact: Fei Ma, Dr.         
Sponsors and Collaborators
Peking Union Medical College

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Responsible Party: Fei Ma, Deputy Director of Oncology Medicine, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT03786575     History of Changes
Other Study ID Numbers: NCC1787
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Fei Ma, Peking Union Medical College:
Breast Neoplasm
Next Generation Sequencing
Endocrine Therapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs