Clinical trial NCT04683757: The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
Official title: A Prospective Cohort Study： the Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer
a Survival Prediction Model
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer

Brief summary: This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.


Eligibility criteria: Inclusion Criteria:

1. At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
2. ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
3. Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
4. Patients who are willing to receive follow-up treatment in the research center.

Exclusion Criteria:

1. ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
2. Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
3. Combined with other malignant tumors or had other malignant tumors in recent 5 years
4. Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
5. Patients with life expectancy less than 3 months

Primary outcomes:
measure: overall survival，OS
timeFrame: 5 years
measure: Tumor specific survival time, CSS
timeFrame: 5 years
Secondary outcomes:
measure: Progression Free Survival，PFS
timeFrame: 2 years
measure: 5-year survival rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital，Sun Yat sen University
state: Guangdong
city: Guanzhou
country: China
facility: Sun Yat-sen Memorial Hospital， Sun Yat-sen University
state: Guangdong
Study officials:
References: