Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic … (NCT03947736) | Clinical Trial Compass
UnknownNot Applicable
Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR
China200 participantsStarted 2018-09-17
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 2020-12-31
2
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.
. Voluntary enrollment, good compliance, can be followed up and observed.
Exclusion criteria
. 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;