Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
NCT ID: NCT04683770
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-07-01
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HR + / HER2 - advanced breast cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Pathological examination confirmed that ER and/or PR were positive and HER-2 was negative (ER expression: immunohistochemical staining \> 1% of tumor cells; PR expression: immunohistochemical staining of tumor cells \> 1%; HER-2 negative: immunohistochemical staining of 0,1 +, or fish / CISH negative)
3. No more than four systematic treatments have been used for advanced diseases
4. It is expected that the patients can be followed up at least once after the treatment plan is formulated.
5. The WHO physical status was 0-2 points, and the expected survival time was not less than 3 months;
6. No more than four systematic treatment regimens have been received in the past for advanced diseases
7. There was at least one measurable lesion (short diameter of lymph node ≥ 15mm) in imaging examination within 2 weeks before enrollment, and a conventional CT scan was performed. The diameter of spiral CT scan was more than or equal to 20 mm or more than 10 mm.
8. Prior treatment-related toxicity should be reduced to NCI CTCAE (version 4.03) ≤ 1 degree (except for hair loss or other toxicity judged by the researcher as having no risk to the safety of patients)
9. Within one week before admission, blood routine examination was basically normal: A. white blood cell count (WBC) ≥ 3.0 × 10 \^ 9 / L; B. neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L; C. platelet count (PLT) ≥ 100 × 10 \^ 9 / L;
10. Within one week before admission, liver, and kidney function tests were basically normal (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) ≤ 1.5 × ULN; B. alanine aminotransferase and aspartate aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastases ≤ 5xuln); C. serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml/min；
Exclusion Criteria
2. Poor compliance or the situation that the researchers think is not suitable to be included in the study;
3. Pregnant or lactating patients;
4. Patients who had received transplantation before;
5. Patients who had previously received stem cell therapy;
6. Patients who have received any immunotherapy that may introduce exogenous DNA and other patients who may introduce exogenous DNA within 4 weeks;
7. Have received more than four systematic treatments for advanced diseases;
8. May interfere with the concomitant diseases or conditions involved in the study, or have any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection);
18 Years
80 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Jianli Zhao
Attending Doctor
Principal Investigators
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Jianli Dr. Zhao, doctor
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Sun Yat Sen Memorial Hospital，Sun Yat sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jianli Zhao
Role: primary
Ying Wang
Role: backup
Other Identifiers
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2020-KY-063
Identifier Type: -
Identifier Source: org_study_id