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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02365805
Eligibility Criteria:
Inclusion Criteria:
* Female gender
* 18 years or older
* Performance Status- ECOG: 0-1
* Histologically confirmed invasive breast cancer
* Primary tumor greater than 2 cm diameter
* Any N (0-3)
* No evidence of metastasis (M0), HER-2/ERBb2 negative.
* Known hormone receptors status.
* Haematopoietic status: Absolute neutrophil count \> 1.5 x 109/L; Platelet count \> 100 x 109/L
* Hemoglobin at least 9 g/dl)
* Hepatic status: Serum total bilirubin \< 1.5 x upper limit of normal (ULN), in the case of known Gilbert's syndrome, a higher serum total bilirubin (\< 2 x ULN) is allowed;AST and ALT \< 2.5 times ULN; Alkaline phosphatase \< 2.5 times ULN)
* Renal status: Creatinine \< 1.5 mg/dl or Cl CR \> 60 ml/m
* For women of childbearing potential Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to randomization.
* Signed informed consent form (ICF).
Exclusion Criteria:
* Received any prior treatment for primary invasive breast cancer.
* Previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated:
* Basal and squamous cell carcinoma of the skin;Carcinoma in situ of the cervix.
* Diagnosis of inflammatory breast cancer.
* Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction uncontrolled hypertension (? 180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic therapy with oxygen.
* Left Ventricular Ejection Fraction of \< 50% measured by echocardiography.
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject?s safety.
* Unresolved or unstable, serious adverse events from prior administration of another investigational drug.
* Active or uncontrolled infection.
* Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF.
* Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies).
* Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial.
* Known immediate or delayed hypersensitivity reaction, idiosyncrasy or contraindication to drugs chemically related to any of the study treatments or their excipients.
* Pregnant or lactating women.
* Refusal to use contraception throughout the study (surgical sterilization, barrier methods associated with spermicidal gels or total abstinence). Use of hormonal contraceptives is not allowed.
* Patient unable to comply with study procedures.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02365805
Study Brief:
Protocol Section:
NCT02365805