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Breast CancerNCT03437837

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

An observational study of Breast Cancer and Neoadjuvant Therapy, run by Peking University First Hospital at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
1,077 participants
Where
12 sitesChina
Study dates
1 May 2017to 29 Sep 2018
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
  • Has operable, histologically confirmed, Stage I, IIA, IIB, IIIA, IIIB or IIIC invasive carcinoma of the breast.
  • Has had neoadjuvant chemotherapy before operation for this breast cancer.
  • Age >=18 to <=75 years old.
  • Has known ER and PR status.
  • Has known HER-2 status.
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  • Has known menopausal status.
  • 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.
  • 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).
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • 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
  • 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
  • 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.
  • 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.
  • Has had baseline bilateral B-type ultrasound，MRI was recommended, but not essential.
  • 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

Who cannot join

  • A patient will be excluded from this study if she meets any of the following criteria:
  • Has bilateral synchronous breast cancer.
  • Has any evidence of metastatic disease: staging work-up, biopsy or physical examination suspicious for malignant disease.
  • Has a history of severe hypersensitivity reaction to chemotherapy drugs or formulation.
  • Has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes.
  • Has peripheral neuropathy >Grade 1.
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  • 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.
  • 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.
  • Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be human immunodeficiency virus (HIV) positive.
  • 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.
  • Is deemed unable to comply with requirements of study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Affiliated Hospital of Academy of Military Medical Sciences

    Beijing, Beijing Municipality, 100071

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Affiliated Union Hospital of Fujian Medical University

    Fuzhou, Fujian, 350001

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • Second Affiliated Hospital of Shantou University Medical College

    Jinan, Shandong, 250033

  • The First Hospital of China Medical University, Shenyang, Liaoning, China

    Shenyang, Liaoning, 110001

  • The 4th Hospital of Hebei medical university

    Shijiazhuang, Hebei, 050011

  • Xijing Hospital, The Fourth Military Medical University

    Xi'an, Shaanxi, 710032

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: 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.

Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Specific Survival (DSS)

    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.

    Measured: 5 years

Secondary outcomes (2)

  1. Disease-free survival (DFS)

    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.

    Measured: 5 years

  2. Overall Survival (OS)

    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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start1 May 2017
  3. Primary completion29 Sep 2018
  4. Study completion29 Sep 2018

Resources

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
Case only
Time perspective
Retrospective
Enrolment
1,077 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437837
Sponsor's protocol ID
CPS+EG-NeoBioscore-Modified
Status last verified
Sep 2020
First submitted
13 Feb 2018
Last updated
28 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu L, Liu Y, Fan Z, Jiang Z, Liu Y, Ling R, Zhang J, Yu Z, Jin F, Wang C, Cui S, Wang S, Mao D, Han B, Wang T, Zhang G, Wang T, Guo B, Yu L, Xu Y, Fu F, Liu Z, Wang S, Luo K, Xiang Q, Zhang Z, Liu Q, Zhou B, Liu Z, Ma C, Tong W, Mao J, Duan X, Cui Y. Assessment of CPS + EG, Neo-Bioscore and Modified Neo-Bioscore in Breast Cancer Patients Treated With Preoperative Systemic Therapy: A Multicenter Cohort Study. Front Oncol. 2021 Mar 16;11:606477. doi: 10.3389/fonc.2021.606477. eCollection 2021.

    PubMed 33796452

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Neoadjuvant Therapy, run by Peking University First Hospital at 12 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 26 inclusion and 11 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: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Specific Survival (DSS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437837, which also lists 1 linked publication.

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 28 Sep 2020.

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