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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437837
• Other study ID #: CPS+EG-NeoBioscore-Modified
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: September 29, 2018

Study information

• Verified date: September 2020
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: September 29, 2018
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Affiliated Union Hospital of Fujian Medical University	Fuzhou	Fujian
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Second Affiliated Hospital of Shantou University Medical College	Jinan	Shandong
China	The First Hospital of China Medical University, Shenyang, Liaoning, China	Shenyang	Liaoning
China	The 4th Hospital of Hebei medical university	Shijiazhuang	Hebei
China	Xijing Hospital, The Fourth Military Medical University	Xi'an	Shaanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years
Secondary	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.	5 years