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

NCT03437837 | Completed

• 1 other identifier: CPS+EG-NeoBioscore-Modified
• Study Type: observational
• Target: 1,077
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Breast Cancer; Neoadjuvant Therapy; Neoplasm Staging; Estrogen Receptor; Histological Grade; HER2; Prognosis; Predictive Value of Tests

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (2)

• Disease-free survival (DFS)

  5 years

• Overall Survival (OS)

  5 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (12)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

Location

Affiliated Union Hospital of Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

The 4th Hospital of Hebei medical university

Shijiazhuang, Hebei, 050011, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

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

Shenyang, Liaoning, 110001, China

Location

Xijing Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Second Affiliated Hospital of Shantou University Medical College

Jinan, Shandong, 250033, China

Location

Related Publications (1)

• 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.

  PMID: 33796452 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician of Breast Disease Center, Associate Professor, M.D.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: May 1, 2017
• Primary Completion: September 29, 2018
• Study Completion: September 29, 2018
• Last Updated: September 28, 2020

Record last verified: 2020-09

Locations

CN (12)