Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT05400993
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 18 years or older and 75 years or younger;
2. All patients were histopathologically confirmed to be estrogen receptor (ER) positive (\& GT; 10%),HER2 receptor negative follows the 2018 ASCO-CAP HER2 negative interpretation guideline criteria;
3. Newly treated patients with stage II-III tumor staging meeting AJCC Version 8 criteria;
4. KPS score ≥70;
5. The functional level of the organ must meet the following requirements:
* Bone marrow function
* ANC ≥ 1.5×10 9 /L (growth factor not used within 14 days);
* PLT ≥ 100×10 9 /L (no corrective treatment within 7 days);
* Hb ≥ 100 g/L (no corrective treatment within 7 days);
* Liver and kidney function
* TBIL ≤1.5 x ULN;
* ALT and AST≤3×ULN;
* BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
6. Able to undergo needle biopsy;
7. Volunteered to participate in the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.
Exclusion Criteria:
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Participants are not allowed to participate in the clinical study under any of the following conditions:
1. Have received any other form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
2. Receiving any other antitumor therapy;
3. Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
4. Stage IV breast cancer;
5. Breast cancer without histopathological diagnosis;
6. Other malignant tumors within the past 5 years, except cured carcinoma in situ of the cervix;
7. Severe heart, liver, kidney and other important organ dysfunction;
8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug taking and absorption;
9. Participated in clinical trials of other drugs within 4 weeks before enrollment;
10. Known history of allergy to the drug components of this regimen; History of immunodeficiency, including HIV positive, HCV, live active hepatitis B or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;
11. History of any heart disease, including :(1) medically required or clinically significant arrhythmia; (2) myocardium infarction; (3) heart failure; (4) Any other heart disease deemed unsuitable for the study by the investigator;
12. Pregnant, lactating women, fertile women with positive baseline pregnancy test or in the entire women of reproductive age who were unwilling to use effective contraception during the trial;
13. According to the investigator's judgment, there are comorbidities (including but) that seriously endanger the patient's safety or affect the patient's ability to complete the study not limited to severe hypertension, severe diabetes, active infection, etc., which cannot be controlled by drugs);
14. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia. The investigator considered the patient unsuitable for the study in any other case.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05400993
Study Brief:
Protocol Section:
NCT05400993