Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR

NCT03947736 | Unknown

• 1 other identifier: NCC1824
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This was a prospective, single-center clinical study. The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and clinical response in patients with recurrent or metastatic breast cancer.

Conditions

Recurrent or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and imaging assessment in patients with recurrent or metastatic breast cancer.

  2020-12-31

• The study was designed to investigate the proportion of predicting in advance the treatment efficacy of recurrent or metastatic breast cancer by plasma HER2 ctDNA.

  2020-12-31

Study Arms (2)

patients with positive HER2 amplification

Diagnostic Test: cfDNA was detected by dPCR

patients with negative HER2 amplification

Diagnostic Test: cfDNA was detected by dPCR

Interventions

cfDNA was detected by dPCR DIAGNOSTIC_TEST

Without drug intervention, the patient's peripheral blood was collected and cfDNA was extracted for digital PCR detection.

patients with negative HER2 amplification; patients with positive HER2 amplification

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with recurrent or metastatic breast cancer

You may qualify if:

• Confirmed by pathology and/or histology/cytology as breast cancer;
• Patients with recurrent or metastatic breast cancer who are 18 to 75 years old, not limited to the first relapse or metastasis;
• There are evaluable tumor lesions;
• Physical strength: ECOG score 0-1;
• The expected survival period is more than 3 months;
• Agree to be collected tissue specimen;
• The patient has no major organ dysfunction, agrees and can implement a treatment plan based on the patient's condition.
• Voluntary enrollment, good compliance, can be followed up and observed.

You may not qualify if:

• Severe vital organs (heart, liver, kidney) dysfunction; clinically significant heart disease, classified by New York Heart Association (NYHA) as grade III-IV heart failure or more severe congestive heart failure or severe Arrhythmia requiring drug intervention; uncontrolled angina, uncontrolled arrhythmia or uncontrollable hypertension, electrocardiogram (ECG)-confirmed myocardial infarction within 6 months;
• Have a history of organ transplantation, splenectomy;
• Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ, or other tumors that have been cured for at least 5 years;
• Moderate or severe renal impairment \[creatinine clearance equal to or lower than 50ml/min (calculated according to Cockroft and Gault equations)\], or serum creatinine \> normal upper limit (ULN); pulmonary function test FEV1 \< 50% of estimated value;
• Parallel surgical treatment of other diseases is required;
• Patients who are pregnant or breast-feeding (women of childbearing age need to be examined for pregnancy); women of childbearing age must take contraceptive measures that the investigator considers effective;
• Patients with or showing signs of disseminated spongiform encephalopathy or family members have the disease;
• In the active period of other acute infectious diseases or chronic infectious diseases;
• Have uncontrolled epilepsy, central nervous system disease or a history of mental disorders;
• People with disabilities or with no legal capacity or legal capacity is limited;
• Those who received a research medication or formulation/treatment (ie, participated in other trials) within 4 weeks prior to enrollment;
• Other situations when the investigators believe that patients should not participate in this trial.
• Quitting criteria:
• The patient suffers from other diseases and needs to be immediately taken to other therapists, and is no longer suitable for sampling test;
• Diagnosis of encephalitis and other inflammatory neuropathies;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Questgenomics: collaborator

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Breast Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr. yuan, Prof

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

peng yuan, Prof

CONTACT

13501270834; yuanpeng01@hotmail.com

YiRan Si, Dr.

CONTACT

18810844632; 15122649164@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 13, 2019
• Study Start: September 17, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

CN (1)