Validation of the CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging Systems After PST of BC in China

September 25, 2020 updated by: XU Ling, Peking University First Hospital

Validation of CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging System After Preoperative Systemic Therapy of Breast Cancer in Multi-center in China

Prognostic assessment after preoperative systemic therapy (PST) plays a vital role in breast cancer patients. The clinical-pathologic staging system incorporating estrogen receptor (ER)-negative disease and nuclear grade 3 tumor pathology (CPS+EG staging system) can effectively predict prognosis after PST. The Neo-Bioscore has been developed by the incorporation of the human epidermal growth factor receptor 2 (HER2) status into the CPS+EG staging system. But in a real world in China, the both staging systems had limits because of trastuzumab administration varied a lot in China from the United States. This retrospective study will validate CPS+EG and Neo-Bioscore system and explored a modified Neo-Bioscore system in multiple centers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1077

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100071
        • Affiliated Hospital of Academy of Military Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Affiliated Union Hospital of Fujian Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • The Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • The 4th Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University, Shenyang, Liaoning, China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, The Fourth Military Medical University
    • Shandong
      • Jinan, Shandong, China, 250033
        • Second Affiliated Hospital of Shantou University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nonmetastatic primary breast cancer patients who were treated with preoperative systemic therapy and surgery and had complete interesting clinicopathological data will be included.

Description

Inclusion Criteria:

A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:

  1. Has operable, histologically confirmed, Stage I, IIA, IIB, IIIA, IIIB or IIIC invasive carcinoma of the breast.
  2. Has had neoadjuvant chemotherapy before operation for this breast cancer.
  3. Age >=18 to <=75 years old.
  4. Has known ER and PR status.
  5. Has known HER-2 status.
  6. Has known menopausal status.
  7. Before PST, Lymph nodes were evaluated by fine needle biopsy (FNB) if the clinically positive, or by sentinel lymph nodes biopsy (SLNB) if the clinically or FNB negative.
  8. Has complete surgical resection of the primary breast tumor after PST: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS).
  9. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

  10. Has laboratory values of

    • White blood cell count >3000/mm3
    • Absolute neutrophil count (ANC) ≥1500/mm3
    • Hemoglobin ≥9.0 g/dL
    • Total bilirubin <ULN
    • Serum creatinine ≤1.5 mg/dL
    • Platelet count ≥100,000/mm3
    • ULN = upper limit of normal

  11. Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within any of the ranges shown below:

    • ALP ≤ upper limits of normal(ULN),and AST or ALT ≤ 5 ULN
    • ULN < ALP ≤2.5 ULN, and AST or ALT ≤ 1.5 ULN
    • 2.5 ULN < ALP ≤5 ULN, and AST or ALT ≤ ULN
  12. Has normal cardiac function as evidenced by an left ventricular ejection fraction (LVEF) >50% by echocardiogram (ECHO), Ejection fraction as determined by ECHO must be within normal limits (WNL) by institutional standard.
  13. Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray or computed tomography (CT) scan. Other scans if done as needed by the patient [e.g., bone scan; abdominal, chest CT; Positron Emission Tomography (PET) or Positron Emission Tomography-Computed Tomography (PET-CT); ultrasound; or Magnetic Resonance Imaging (MRI)] should indicate no evidence of metastatic disease.
  14. Has had baseline bilateral B-type ultrasound，MRI was recommended, but not essential.
  15. If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive only) to avoid pregnancy duration the study and for a period of 3 months thereafter

Exclusion Criteria:

A patient will be excluded from this study if she meets any of the following criteria:

  1. Has bilateral synchronous breast cancer.
  2. Has any evidence of metastatic disease: staging work-up, biopsy or physical examination suspicious for malignant disease.
  3. Has a history of severe hypersensitivity reaction to chemotherapy drugs or formulation.
  4. Has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes.
  5. Has peripheral neuropathy >Grade 1.
  6. Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.
  7. Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral [including clinically defined acquired immune deficiency syndrome (AIDS)], bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or central nervous system (CNS) disorders deemed by the Treating Physician to be clinically significant, precluding informed consent.
  8. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be human immunodeficiency virus (HIV) positive.
  9. Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS), which could affect the diagnosis or assessment of any of the study drugs.
  10. Is deemed unable to comply with requirements of study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease Specific Survival (DSS)
Time Frame: 5 years
DSS will be calculated from the time of diagnosis to death resulting from breast cancer. Patients still alive at the time of the analysis will be censored using the date they were last known to be alive.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 5 years
DFS, defined as the time from the time of post-PST breast cancer surgery to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant metastasis, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free.
5 years
Overall Survival (OS)
Time Frame: 5 years
OS will be measured as the time from the date of diagnosis to the date of death. Patients still alive at the time of the analysis will be censored using the date they were last known to be alive.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPS+EG-NeoBioscore-Modified

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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