Breast NeoplasmsNCT04059003
CTC Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
An observational study of Breast Neoplasms, run by Shengjing Hospital at 2 sites in China.
Trial summary
Chemotherapy before operation for malignant tumors can reduce the size of tumors to a certain extent, even eliminate micrometastases. Chemotherapy can also detect the sensitivity of chemotherapeutic drugs and create opportunities for breast-conserving or surgical treatment for patients. 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?
- Taxanes or/and anthracycline-based therapy
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2019to 31 Aug 2024
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Totally 200 patients who meet the inclusion and exclusion criteria will be consecutively enrolled in the trial and grouped according to their sensitivity.
Who may be able to join
- triple-negative breast cancer confirmed by breast biopsy;
- stage III breast cancer (IIIA-C) assessed by CT or MRI;
- neoadjuvant chemotherapy;
- informed consent of patients and their family members.
Who cannot join
- use of second-line chemotherapy regimen;
- bilateral breast cancer;
- inflammatory breast cancer;
- pregnant or breast-feeding;
- distant metastasis;
- a history of other cancers or chest radiotherapy;
- a history of abnormal blood test or other infectious symptoms.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Shengyang, Liaoning, 110042
Jianyi Li, Dr., 13390127607, sjbreast@yeah.net
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Jianyi Li, +8618940257177, sjbreast@yeah.net
About this study
Official title: Circulating Tumor Cell Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: a Cohort Trial
Chemotherapy before operation for malignant tumors can reduce the size of tumors to a certain extent, even eliminate micrometastases. Chemotherapy can also detect the sensitivity of chemotherapeutic drugs and create opportunities for breast-conserving or surgical treatment for patients. This may lead to high survival opportunities for triple-negative breast cancer patients who are not sensitive to targeted therapy or endocrine therapy. However, during neoadjuvant therapy, CT or MRI tests are needed to monitor the patient's condition. Therefore, if there is any deterioration, to consider changing the treatment regimen or immediately carrying out surgery is necessary. However, because of the need for multiple imaging examinations during neoadjuvant therapy, which will increase medical costs, to explore a cheaper examination method is necessary . Circulating tumor cells in peripheral blood are derived from the shedding of breast cancer lesions. Detection of these circulating tumor cells may monitor the therapeutic effect on breast cancer, and the cost of detecting circulating tumor cells is much lower than that of conventional PET-CT, which can obviously reduce the medical costs of patients. However, there is no clinical study on the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy in the treatment of triple-negative breast cancer in and outside China.
Read the detailed description
Triple-negative breast cancer refers to breast cancer with negative human epidermal growth factor receptor 2, estrogen receptor and progesterone receptor. Triple-negative breast cancer has poor differentiation, high invasiveness and high recurrence rate, accounting for 15.0%-23.8% of breast cancer. Due to the phenotypic specificity of triple-negative breast cancer, both targeted therapy and endocrine therapy are insensitive, making chemotherapy an important part in the treatment of triple-negative breast cancer.
In 1982, Frei proposed the concept of neoadjuvant chemotherapy, which is to apply chemotherapy before surgery for malignant tumors. Chemotherapy can reduce the size of tumors to some extent, even eliminate micrometastases, detect the sensitivity of chemotherapy drugs, and create opportunities for patients to have breast-conserving or surgical treatment. For triple-negative breast cancer, neoadjuvant chemotherapy with synchronous combination of anthracyclines and taxanes or intensive sequential combination of anthracyclines and taxanes is the first choice. Simultaneously, chemotherapeutic drugs such as platinum, albumin, and paclitaxel as well as poly-ADP-ribose polymerase inhibitors can be added according to the patient's condition. However, during neoadjuvant therapy, a CT or MRI test is needed to monitor the patient's condition, so if there is any deterioration, to consider changing the treatment plan or immediately performing surgery is necessary. However, because of the need for multiple imaging examinations during neoadjuvant therapy, which increases the medical costs, to explore a low cost inspection method is necessary.
Circulating tumor cells are a new type of tumor molecular marker. Circulating tumor cells in peripheral blood originate from breast cancer (primary and metastatic lesions) shedding. Detection of these circulating tumor cells may monitor the therapeutic effect on breast cancer. The cost of detecting circulating tumor cells is much lower than that of conventional PET-CT, which can noticeably reduce medical expenses of patients. However, there is no clinical study on the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy for triple-negative breast cancer in and outside China. This study aims to explore the correlation between the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy for triple-negative breast cancer, and to compare the time intervals between the changes of circulating tumor cells and the changes of efficacy in patients with different sensitivities of neoadjuvant chemotherapy, so as to provide experimental evidence for predicting the efficacy of neoadjuvant chemotherapy by observing the changes of circulating tumor cells in clinic.
- Conditions
- Breast Neoplasms
- Being tested
- Taxanes or/and anthracycline-based therapy
- Keywords
- Biomarkers, Tumor, Positron Emission Tomography, Computed Tomography
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxanes or/and anthracycline-based therapyDrug
Taxanes or/and anthracycline-based therapy will be used in this group. That is, intravenous injection of 90 mg/m2 epirubicin (trade name: Pharmorubicin, Pfizer, Shanghai, China; drug approval number: H20100155) + 135 mg/m2 paclitaxel liposome (trade name: Taxotere, Sanofi (Hangzhou) Pharmaceutical Co., Ltd., Hangzhou, China; drug approval number: J20090104), every 3 weeks as a course of treatment. The efficacy will be evaluated every 2 courses. After the 6th course, mastectomy will be performed according to the patient's conditions.
| Study group | Role | What they receive |
|---|---|---|
| Sensitivity group | 100 patients will be assigned into sensitivity group according to the actual situation of them. Receives: Drug: Taxanes or/and anthracycline-based therapy | |
| Drug resistance group | 100 patients will be assigned into drug resistance according to the actual situation of them. Receives: Drug: Taxanes or/and anthracycline-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of neoadjuvant chemotherapy
The efficacy will be evaluated by the response evaluation criteria in solid tumors (RECIST) score, which is based on CT or X-ray results. (1) Complete response (CR): disappearance of all lesions; (2) partial response (PR): 30% decrease in sum of all target lesions in longest axis measurement; (3) stable disease (SD): the sum of the longest diameter of all lesions decreases but does not reach PR or increases but does not reach PD; (4) progressive disease (PD): 20% increase in the sum of the longest diameter or appearance of new lesions. SD: One or more non-target lesions and/or tumor markers are higher than normal and persistent.
Measured: At 18 weeks
Secondary outcomes (3)
Efficacy of neoadjuvant chemotherapy
The efficacy will be evaluated by the response evaluation criteria in solid tumors (RECIST) score, which is based on CT or X-ray results. (1) Complete response (CR): disappearance of all lesions; (2) partial response (PR): 30% decrease in sum of all target lesions in longest axis measurement; (3) stable disease (SD): the sum of the longest diameter of all lesions decreases but does not reach PR or increases but does not reach PD; (4) progressive disease (PD): 20% increase in the sum of the longest diameter or appearance of new lesions. SD: One or more non-target lesions and/or tumor markers are higher than normal and persistent.
Measured: At 6 and 12 weeks
Detection of circulating tumor cells
At 3 weeks of neoadjuvant chemotherapy, 2.5 ml of blood will be taken from median elbow vein of upper arm, and the number of circulating tumor cells is ≤ 2 or CD133 ≤ 1.
Measured: At 3 weeks of neoadjuvant chemotherapy
Miller-Payne grading score
The Miller-Payne grading system is as follows: Grade 1: no reduction in overall cellularity; grade 2: up to 30% reduction of cellularity; grade 3: between an estimated 30% and 90% reduction in tumor cellularity; grade 4: a marked disappearance of more than 90% of tumor cells; grade 5: no invasive malignant cells identifiable in sections from the site of the tumor, but ductal carcinoma in situ may be present.
Measured: Before and 18 weeks after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Nov 2019
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (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
- 200 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, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059003
- Sponsor's protocol ID
- Shengjing-LJY03
- Status last verified
- Jan 2022
- First submitted
- 14 Aug 2019
- Last updated
- 20 Jan 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cell Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: a Cohort Trial
- ClinicalTrials.gov ID
- NCT04059003
- Acronym / sponsor ID
- Shengjing-LJY03
- Conditions
- Breast Neoplasms
- Keywords
- Biomarkers, Tumor, Positron Emission Tomography, Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 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.
Chemotherapy before operation for malignant tumors can reduce the size of tumors to a certain extent, even eliminate micrometastases. Chemotherapy can also detect the sensitivity of chemotherapeutic drugs and create opportunities for breast-conserving or surgical treatment for patients. This may lead to high survival opportunities for triple-negative breast cancer patients who are not sensitive to targeted therapy or endocrine therapy. However, during neoadjuvant therapy, CT or MRI tests are needed to monitor the patient's condition. Therefore, if there is any deterioration, to consider changing the treatment regimen or immediately carrying out surgery is necessary. However, because of the need for multiple imaging examinations during neoadjuvant therapy, which will increase medical costs, to explore a cheaper examination method is necessary . Circulating tumor cells in peripheral blood are derived from the shedding of breast cancer lesions. Detection of these circulating tumor cells may monitor the therapeutic effect on breast cancer, and the cost of detecting circulating tumor cells is much lower than that of conventional PET-CT, which can obviously reduce the medical costs of patients. However, there is no clinical study on the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy in the treatment of triple-negative breast cancer in and outside China.
Detailed description
Triple-negative breast cancer refers to breast cancer with negative human epidermal growth factor receptor 2, estrogen receptor and progesterone receptor. Triple-negative breast cancer has poor differentiation, high invasiveness and high recurrence rate, accounting for 15.0%-23.8% of breast cancer. Due to the phenotypic specificity of triple-negative breast cancer, both targeted therapy and endocrine therapy are insensitive, making chemotherapy an important part in the treatment of triple-negative breast cancer.
In 1982, Frei proposed the concept of neoadjuvant chemotherapy, which is to apply chemotherapy before surgery for malignant tumors. Chemotherapy can reduce the size of tumors to some extent, even eliminate micrometastases, detect the sensitivity of chemotherapy drugs, and create opportunities for patients to have breast-conserving or surgical treatment. For triple-negative breast cancer, neoadjuvant chemotherapy with synchronous combination of anthracyclines and taxanes or intensive sequential combination of anthracyclines and taxanes is the first choice. Simultaneously, chemotherapeutic drugs such as platinum, albumin, and paclitaxel as well as poly-ADP-ribose polymerase inhibitors can be added according to the patient's condition. However, during neoadjuvant therapy, a CT or MRI test is needed to monitor the patient's condition, so if there is any deterioration, to consider changing the treatment plan or immediately performing surgery is necessary. However, because of the need for multiple imaging examinations during neoadjuvant therapy, which increases the medical costs, to explore a low cost inspection method is necessary.
Circulating tumor cells are a new type of tumor molecular marker. Circulating tumor cells in peripheral blood originate from breast cancer (primary and metastatic lesions) shedding. Detection of these circulating tumor cells may monitor the therapeutic effect on breast cancer. The cost of detecting circulating tumor cells is much lower than that of conventional PET-CT, which can noticeably reduce medical expenses of patients. However, there is no clinical study on the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy for triple-negative breast cancer in and outside China. This study aims to explore the correlation between the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy for triple-negative breast cancer, and to compare the time intervals between the changes of circulating tumor cells and the changes of efficacy in patients with different sensitivities of neoadjuvant chemotherapy, so as to provide experimental evidence for predicting the efficacy of neoadjuvant chemotherapy by observing the changes of circulating tumor cells in clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensitivity group | – | Drug: Taxanes or/and anthracycline-based therapy100 patients will be assigned into sensitivity group according to the actual situation of them. |
| Drug resistance group | – | Drug: Taxanes or/and anthracycline-based therapy100 patients will be assigned into drug resistance according to the actual situation of them. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Totally 200 patients who meet the inclusion and exclusion criteria will be consecutively enrolled in the trial and grouped according to their sensitivity.
Key inclusion criteria (4 listed)
- triple-negative breast cancer confirmed by breast biopsy;
- stage III breast cancer (IIIA-C) assessed by CT or MRI;
- neoadjuvant chemotherapy;
- informed consent of patients and their family members.
Key exclusion criteria (7 listed)
- use of second-line chemotherapy regimen;
- bilateral breast cancer;
- inflammatory breast cancer;
- pregnant or breast-feeding;
- distant metastasis;
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 |
|---|---|---|
| Taxanes or/and anthracycline-based therapyTaxanes or/and anthracycline-based therapy will be used in this group. That is, intravenous injection of 90 mg/m2 epirubicin (trade name: Pharmorubicin, Pfizer, Shanghai, China; drug approval number: H20100155) + 135 mg/m2 paclitaxel liposome (trade name: Taxotere, Sanofi (Hangzhou) Pharmaceutical Co., Ltd., Hangzhou, China; drug approval number: J20090104), every 3 weeks as a course of treatment. The efficacy will be evaluated every 2 courses. After the 6th course, mastectomy will be performed according to the patient's conditions. | Drug | Drug resistance group, Sensitivity group |
Primary outcome
Efficacy of neoadjuvant chemotherapy
Time frame: At 18 weeks
The efficacy will be evaluated by the response evaluation criteria in solid tumors (RECIST) score, which is based on CT or X-ray results. (1) Complete response (CR): disappearance of all lesions; (2) partial response (PR): 30% decrease in sum of all target lesions in longest axis measurement; (3) stable disease (SD): the sum of the longest diameter of all lesions decreases but does not reach PR or increases but does not reach PD; (4) progressive disease (PD): 20% increase in the sum of the longest diameter or appearance of new lesions. SD: One or more non-target lesions and/or tumor markers are higher than normal and persistent.
3 secondary outcomes
Efficacy of neoadjuvant chemotherapy
Time frame: At 6 and 12 weeks
Detection of circulating tumor cells
Time frame: At 3 weeks of neoadjuvant chemotherapy
Miller-Payne grading score
Time frame: Before and 18 weeks after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Jianyi Li 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 4 inclusion and 7 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 20 Jan 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?
Results are not available in the source record.
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?
Efficacy of neoadjuvant chemotherapy (time frame: At 18 weeks). 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 20 Jan 2022.