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Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer

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ClinicalTrials.gov Identifier: NCT04065321
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jianyi Li, Shengjing Hospital

Brief 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. 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.


Condition or disease Intervention/treatment
Breast Neoplasms Procedure: PET-CT examination Procedure: Peripheral blood detection

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Control group
250 patients will be assigned into control group.
Procedure: PET-CT examination
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.

Trial group
250 patients will be assigned into trial group.
Procedure: Peripheral blood detection
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Overall survival refers to the time from breast cancer excision to death due to any cause


Other Outcome Measures:
  1. Total length of hospital stay [ Time Frame: 5 years ]
    Total length of hospital stay for patients during the reexamination

  2. Average length of hospital stay per reexamination [ Time Frame: 5 years ]
    Average length of hospital stay per reexamination = total length of hospital stay/number of reexaminations

  3. Total cost of reexaminations [ Time Frame: 5 years ]
    Total cost of all reexaminations, including medical insurance and other insurance reimbursements

  4. Average cost per reexamination [ Time Frame: 5 years ]
    Average cost per reexamination = total cost of reexaminations/number of reexaminations



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • estrogen receptor (≥ 10%), progesterone receptor (≥ 10%) and epidermal growth factor receptor 2 negative;
  • proliferation index Ki-67 < 14%;
  • 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.

Exclusion Criteria:

  • Bilateral breast cancer;
  • inflammatory breast cancer;
  • pregnancy or lactation;
  • history of other cancers or chest radiotherapy.

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): NCT04065321


Contacts
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Contact: Jianyi Li +8618940257177 sjbreast@yeah.net

Sponsors and Collaborators
Shengjing Hospital
Investigators
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Principal Investigator: Jianyi Li, MD Shengjing Hospital

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Responsible Party: Jianyi Li, Principal Investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT04065321     History of Changes
Other Study ID Numbers: Shengjing-LJY04
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianyi Li, Shengjing Hospital:
Circulating tumor cells
PET
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers