Clinical trial NCT03437837: Validation of the CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging Systems After PST of BC in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Neoadjuvant Therapy
Neoplasm Staging
Estrogen Receptor
Histological Grade
HER2
Prognosis
Predictive Value of Tests
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease Specific Survival (DSS)
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: Affiliated Union Hospital of Fujian Medical University
state: Fujian
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The 4th Hospital of Hebei medical university
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University, Shenyang, Liaoning, China
state: Liaoning
city: Xi'an
country: China
facility: Xijing Hospital, The Fourth Military Medical University
state: Shaanxi
city: Jinan
country: China
facility: Second Affiliated Hospital of Shantou University Medical College
state: Shandong
Study officials:
References:
citation: 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.