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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04297267
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 70 years old
* Patients with histologically confirmed unilateral invasive ductal carcinoma(according to WHO histologically type)
* Tumor clinical staged as IIB-IIIB before neoadjuvant chemotherapy (according to the 7th AJCC edition).
* After standard treatment (6-8 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs, must not contain platinum), assessed by the surgery, the original site for non - pCR (MP class 1-4) or lymph nodes are still positive for patients.
* No gross or microscopic tumor residual after resection.
* Patients with clear ER/PR/Her2 receptor, and ER/PR/Her2 are all negative(Specific definition: immunohistochemical detection of ER \< 1% positive tumor cell is defined as the ER negative, PR \< 1% positive tumor cells is defined as the PR negative, Her2 0-1 or Her2 2 + but after FISH or CISH tested negatie for c (no amplification) is defined as the Her2-negative).
* No evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is M0.
* Patients without peripheral neuropathy or I peripheral neurotoxicity.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
* Patients recovered well after surgery, at least 1 weeks after the operation.
* Adequate marrow: White blood cells count≥3000/μL,neutrophil count ≥1500/μL, hemoglobin ≥9g/dL and platelet count ≥75000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
* Adequate renal function: Serum creatinine ≤ 1.5ULN.
* Contraception during the treatment of child-bearing women.
* Adequate cardiac function :Left ventricular ejection fraction (LVEF) \> 50%.
* Patients must be informed of the investigational nature of this study and give written informed consent.
* Patients without serious heart, lung, liver, kidney and other important organs disease history.
* Patients have good compliance.
Exclusion Criteria:
* Patients with bilateral breast cancer or carcinoma in situ(DCIS/LCIS).
* Metastasis of any part except axillary lymph nodes.
* Clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy.
* There have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer.
* Patients have been enrolled in other clinical trials.
* Patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study.
* Patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension \>160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization.
* Pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.)
* Child-bearing women who are unwilling to take effective contraceptive measures in the course of research.
* Patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial).
* Persons without personal freedom and independent civil capacity.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04297267
Study Brief:
Protocol Section:
NCT04297267