Breast NeoplasmsNCT04065321
Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer
An observational study of Breast Neoplasms, run by Shengjing Hospital at 2 sites in China.
Trial summary
The incidence of breast cancer in Chinese women has increased year by year, and luminal A breast cancer commonly occurs in early-stage and postmenopausal women. This type of breast cancer is not sensitive to chemotherapy, although it has a low mortality rate and distant metastasis rate. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- PET-CT examination and Peripheral blood detection
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2019to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- Adult
Study population: 500 patients will be recruited from outpatients and admission office of Shengjing Hospital of China Medical University by posting recruitment notice listing the study details on the bulletin board. The patients will be randomly divided into trial group and control group, with 250 patients per group.
Who may be able to join
- estrogen receptor (≥ 10%), progesterone receptor (≥ 10%) and epidermal growth factor receptor 2 negative;
- proliferation index Ki-67 < 20%;
- no lymph node metastasis;
- systemic therapy (chemotherapy, radiotherapy and endocrine therapy) in accordance with the National Comprehensive Cancer Network guidelines;
- provision of informed consent of patients and their families.
Who cannot join
- Bilateral breast cancer;
- inflammatory breast cancer;
- pregnancy or lactation;
- history of other cancers or chest radiotherapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Jianyi Li, MD, 8618940257177, sjbreast@yeah.net
- Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Jianyi Li, Dr., 13390127607, sjbreast@yeah.net
About this study
Official title: Effect of Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer Without Lymph Node Metastasis Instead of Conventional Imaging Examination After Operation: a Non-Inferiority Randomized Controlled Clinical Trial
The incidence of breast cancer in Chinese women has increased year by year, and luminal A breast cancer commonly occurs in early-stage and postmenopausal women. This type of breast cancer is not sensitive to chemotherapy, although it has a low mortality rate and distant metastasis rate. Studies have shown that luminal A breast cancer is sensitive to endocrine therapy. Patients with breast cancer who undergo excision should be followed up and their prognosis should be monitored regularly. At present, imaging detection is mainly used in the conventional follow-up of breast cancer, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed.
Recent studies have found that circulating tumor cells can be used as a new type of tumor molecular marker, which can be used to diagnose tumors, judge the prognosis and monitor the efficacy by detecting the number and characteristic protein expression of circulating tumor cells. Because circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced.
This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
Read the detailed description
Breast cancer ranks first in the incidence of female malignant tumors and second in mortality. It is mainly classified into luminal A, luminal B, human epidermal growth factor receptor 2 positive, basal-like and other special types of breast cancer. Epidemiological studies have shown that the incidence of luminal A breast cancer is 44.5-69.0%, mostly in early-stage patients and postmenopausal women, with a low mortality rate and distant metastasis rate. Luminal A breast cancer is usually invasive. Although it is not sensitive to chemotherapy, luminal A breast cancer is sensitive to endocrine therapy. Therefore, the treatment of luminal A breast cancer is a combination of surgery, chemotherapy, radiotherapy and endocrine therapy.
After surgical removal of breast cancer, follow-up should be conducted according to the National Comprehensive Cancer Network guidelines to monitor the prognosis at any time. Conventional follow-up is mainly based on imaging examination, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed.
Circulating tumor cells are tumor cells that fall off from solid tumors (primary and metastatic foci) and enter the peripheral blood. In recent 30 years, circulating tumor cells have become one of the new tumor molecular markers. Detection of the number and protein expression of circulating tumor cells can diagnose the disease, judge the prognosis and monitor the therapeutic effect. Epithelial-mesenchymal transition and overexpression of epithelial cell adhesion molecule in circulating tumor cells suggest that the prognosis of cancer patients is not good. By comparing the number of circulating tumor cells in blood before and after surgery or radiotherapy and chemotherapy,whether the treatment is effective or not can be judged, which has important clinical research and application value. Currently, many clinical trials have used circulating tumor cells to monitor the prognosis in breast cancer. Circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, and PET-CT can only find subclinical lesions 4-6 weeks in advance. Thus, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced.
This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
- Conditions
- Breast Neoplasms
- Being tested
- PET-CT examination, Peripheral blood detection
- Keywords
- Circulating tumor cells, PET
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT examinationProcedure or surgery
All patients in the control group will undergo PET-CT examination after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years.
Peripheral blood detectionProcedure or surgery
All patients in the trial group will be followed up after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years. Peripheral blood will be collected for detection of circulating tumor cells at each follow-up. If circulating tumor cells are abnormal (number of circulating tumor cells ≥ 2 or CD133 ≥ 1), PET-CT will be performed immediately.
| Study group | Role | What they receive |
|---|---|---|
| Control group | 250 patients will be assigned into control group. Receives: Procedure: PET-CT examination | |
| Trial group | 250 patients will be assigned into trial group. Receives: Procedure: Peripheral blood detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival refers to the period from breast cancer excision to local recurrence, distant metastasis confirmed by clinical evidence, diagnosis of the second primary tumor or death of the patient.
Measured: 5 years
Secondary outcomes (1)
Overall survival
Overall survival refers to the time from breast cancer excision to death due to any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Shengjing Hospital
- Investigators
- Jianyi Li, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065321
- Sponsor's protocol ID
- Shengjing-LJY04
- Status last verified
- May 2022
- First submitted
- 21 Aug 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer Without Lymph Node Metastasis Instead of Conventional Imaging Examination After Operation: a Non-Inferiority Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04065321
- Acronym / sponsor ID
- Shengjing-LJY04
- Conditions
- Breast Neoplasms
- Keywords
- Circulating tumor cells, PET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 22 Aug 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.
The incidence of breast cancer in Chinese women has increased year by year, and luminal A breast cancer commonly occurs in early-stage and postmenopausal women. This type of breast cancer is not sensitive to chemotherapy, although it has a low mortality rate and distant metastasis rate. Studies have shown that luminal A breast cancer is sensitive to endocrine therapy. Patients with breast cancer who undergo excision should be followed up and their prognosis should be monitored regularly. At present, imaging detection is mainly used in the conventional follow-up of breast cancer, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed.
Recent studies have found that circulating tumor cells can be used as a new type of tumor molecular marker, which can be used to diagnose tumors, judge the prognosis and monitor the efficacy by detecting the number and characteristic protein expression of circulating tumor cells. Because circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced.
This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
Detailed description
Breast cancer ranks first in the incidence of female malignant tumors and second in mortality. It is mainly classified into luminal A, luminal B, human epidermal growth factor receptor 2 positive, basal-like and other special types of breast cancer. Epidemiological studies have shown that the incidence of luminal A breast cancer is 44.5-69.0%, mostly in early-stage patients and postmenopausal women, with a low mortality rate and distant metastasis rate. Luminal A breast cancer is usually invasive. Although it is not sensitive to chemotherapy, luminal A breast cancer is sensitive to endocrine therapy. Therefore, the treatment of luminal A breast cancer is a combination of surgery, chemotherapy, radiotherapy and endocrine therapy.
After surgical removal of breast cancer, follow-up should be conducted according to the National Comprehensive Cancer Network guidelines to monitor the prognosis at any time. Conventional follow-up is mainly based on imaging examination, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed.
Circulating tumor cells are tumor cells that fall off from solid tumors (primary and metastatic foci) and enter the peripheral blood. In recent 30 years, circulating tumor cells have become one of the new tumor molecular markers. Detection of the number and protein expression of circulating tumor cells can diagnose the disease, judge the prognosis and monitor the therapeutic effect. Epithelial-mesenchymal transition and overexpression of epithelial cell adhesion molecule in circulating tumor cells suggest that the prognosis of cancer patients is not good. By comparing the number of circulating tumor cells in blood before and after surgery or radiotherapy and chemotherapy,whether the treatment is effective or not can be judged, which has important clinical research and application value. Currently, many clinical trials have used circulating tumor cells to monitor the prognosis in breast cancer. Circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, and PET-CT can only find subclinical lesions 4-6 weeks in advance. Thus, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced.
This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Procedure: PET-CT examination250 patients will be assigned into control group. |
| Trial group | – | Procedure: Peripheral blood detection250 patients will be assigned into trial group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 500 patients will be recruited from outpatients and admission office of Shengjing Hospital of China Medical University by posting recruitment notice listing the study details on the bulletin board. The patients will be randomly divided into trial group and control group, with 250 patients per group.
Key inclusion criteria (5 listed)
- estrogen receptor (≥ 10%), progesterone receptor (≥ 10%) and epidermal growth factor receptor 2 negative;
- proliferation index Ki-67 < 20%;
- no lymph node metastasis;
- systemic therapy (chemotherapy, radiotherapy and endocrine therapy) in accordance with the National Comprehensive Cancer Network guidelines;
- provision of informed consent of patients and their families.
Key exclusion criteria (4 listed)
- Bilateral breast cancer;
- inflammatory breast cancer;
- pregnancy or lactation;
- history of other cancers or chest radiotherapy.
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 |
|---|---|---|
| PET-CT examinationAll patients in the control group will undergo PET-CT examination after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years. | Procedure or surgery | Control group |
| Peripheral blood detectionAll patients in the trial group will be followed up after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years. Peripheral blood will be collected for detection of circulating tumor cells at each follow-up. If circulating tumor cells are abnormal (number of circulating tumor cells ≥ 2 or CD133 ≥ 1), PET-CT will be performed immediately. | Procedure or surgery | Trial group |
Primary outcome
Disease-free survival
Time frame: 5 years
Disease-free survival refers to the period from breast cancer excision to local recurrence, distant metastasis confirmed by clinical evidence, diagnosis of the second primary tumor or death of the patient.
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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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.
Jianyi Li, MD principal investigator
Shengjing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Shengjing Hospital at 2 sites 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyi Li (+8618940257177, sjbreast@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 5 years). 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 5 May 2022.