Recurrent or Metastatic Breast CancerNCT03947736
Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR
An observational study of Recurrent or Metastatic Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent or Metastatic Breast Cancer
- What is being tested?
- cfDNA was detected by dPCR
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2018to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with recurrent or metastatic breast cancer
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- After the enrollment, it is clearly determined that the subject does not meet the requirements of the subject;
- The investigator believes that the withdrawal of the trial is in the best interest of the subject;
- Pregnancy;
- Poor compliance, two consecutive failures to accept testing as planned;
- The patient him/herself or the researcher believes that it is medically required to be withdrawn from the study.
- For subjects who discontinued the study early, the reason for the early withdrawal should be recorded, and the time of the last visit should be recorded, and the inspection items at the time of early termination of the study should be completed in the last visit as much as possible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
peng yuan, Prof, 13501270834, yuanpeng01@hotmail.com
YiRan Si, Dr., 18810844632, 15122649164@163.com
About this study
Official title: Detection of HER2 Amplification Status and Dynamic Monitoring of Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR
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.
Read the detailed description
Patients were divided into two groups according to ctDNA HER2 amplification status by dPCR method. Group A consisted of patients with positive HER2 amplification at the time of enrollment. Plasma HER2 amplification status was measured by dPCR during dynamic monitoring. GroupB consists of patients with negative HER2 amplification when enrolled. Plasma samples were collected before treatment and breast cancer hotspot mutations were detected with NGS, According to the NGS test results, patient's specific mutations were analyzed and selected, which and plasma HER2 amplification status were measured by dPCR during dynamic monitoring.
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. And also to investigate the proportion of predicting in advance the treatment efficacy of recurrent or metastatic breast cancer by plasma HER2 ctDNA, as well as the median time difference between predicted clinical efficacy by changes in abundance of plasma HER2 amplification specific mutations and medical imaging evaluation in patients.
The study only focus on ctDNA detection and does not involve any interventions.
- Conditions
- Recurrent or Metastatic Breast Cancer
- Being tested
- cfDNA was detected by dPCR
- Medical subject headings
- Recurrence, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA was detected by dPCRDiagnostic test
Without drug intervention, the patient's peripheral blood was collected and cfDNA was extracted for digital PCR detection.
| Study group | Role | What they receive |
|---|---|---|
| patients with positive HER2 amplification | Not described Receives: Diagnostic Test: cfDNA was detected by dPCR | |
| patients with negative HER2 amplification | Not described Receives: Diagnostic Test: cfDNA was detected by dPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2020-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start17 Sep 2018
- Primary completion31 Dec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Questgenomics
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Dr. yuan, Prof, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947736
- Sponsor's protocol ID
- NCC1824
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of HER2 Amplification Status and Dynamic Monitoring of Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR
- ClinicalTrials.gov ID
- NCT03947736
- Acronym / sponsor ID
- NCC1824
- Conditions
- Recurrent or Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Questgenomics
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients were divided into two groups according to ctDNA HER2 amplification status by dPCR method. Group A consisted of patients with positive HER2 amplification at the time of enrollment. Plasma HER2 amplification status was measured by dPCR during dynamic monitoring. GroupB consists of patients with negative HER2 amplification when enrolled. Plasma samples were collected before treatment and breast cancer hotspot mutations were detected with NGS, According to the NGS test results, patient's specific mutations were analyzed and selected, which and plasma HER2 amplification status were measured by dPCR during dynamic monitoring.
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. And also to investigate the proportion of predicting in advance the treatment efficacy of recurrent or metastatic breast cancer by plasma HER2 ctDNA, as well as the median time difference between predicted clinical efficacy by changes in abundance of plasma HER2 amplification specific mutations and medical imaging evaluation in patients.
The study only focus on ctDNA detection and does not involve any interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with positive HER2 amplification | – | Diagnostic Test: cfDNA was detected by dPCR |
| patients with negative HER2 amplification | – | Diagnostic Test: cfDNA was detected by dPCR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with recurrent or metastatic breast cancer
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cfDNA was detected by dPCRWithout drug intervention, the patient's peripheral blood was collected and cfDNA was extracted for digital PCR detection. | Diagnostic test | patients with negative HER2 amplification, patients with positive HER2 amplification |
Primary outcome
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.
Time frame: 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.
Time frame: 2020-12-31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. yuan, Prof study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent or Metastatic Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact peng yuan, Prof (13501270834, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2020-12-31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.