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:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01093235
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* HER2-negative disease
* IHC 0/1 OR IHC 2+ and FISH negative
* Must meet 1 of the following criteria:
* Unifocal tumor meeting 1 of the following criteria:
* T2 or T3 tumors (radiological size \> 20 mm)
* T4 tumor of any size with direct extension to the chest wall or the skin
* Inflammatory carcinoma with tumor of any size
* Multifocal tumor meeting the following criteria:
* The sum of each tumors' maximum diameter must be ≥ 20 mm (total radiological tumor size ≥ 20 mm)
* Other locally advanced disease meeting 1 of the following criteria:
* Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter \> 20 mm or clinical N2) and primary breast tumor of any diameter
* Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter \> 20 mm or clinical N2), without a primary breast tumor identified and the presence of breast cancer in a lymph node must be histopathologically confirmed by lymph node biopsy (tru-cut or whole lymph node)
* Embedded paraffin tumor block available from pre-chemotherapy biopsy and surgical specimen
* Bilateral disease allowed
* No evidence of metastatic disease
* No prior breast cancer except for ductal carcinoma in situ of the breast surgically cured \> 10 years ago
* Any hormone receptor status
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* WBC \> 3 x 10\^9/L
* Hemoglobin \> 10 g/dL
* Platelet count \> 100 x 10\^9/L
* AST/ALT ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* Bilirubin normal
* Isolated elevation of bilirubin to ≤ 3 times ULN with a presumptive diagnosis of Gilbert syndrome allowed if AST/ALT and alkaline phosphatase are within normal limits
* Creatinine ≤ 1.5 times ULN
* PT and PTT/aPTT ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* Must be fit to receive chemotherapy on this trial, in the opinion of the responsible clinician, as indicated by the following criteria:
* No clinically significant cardiac abnormalities
* No myocardial infarction within the past 6 months
* LVEF normal (at least 50%) by MUGA scan or echocardiogram
* No prior ischemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, inflammatory bowel disease, gastroduodenal ulcer, symptomatic diverticulitis, or bleeding diathesis
* No uncontrolled hypertension (systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg) with or without antihypertensive medication
* Patients with initial blood pressure elevations are eligible provided initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria
* No other previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast treated by surgery only and disease-free for 10 years
* No concurrent medical or psychiatric problem that might prevent completion of treatment or follow-up
* No presence of active uncontrolled infection
* No history of nephritic or nephrotic syndrome
* No traumatic injury within the past 28 days
* No evidence of other disease that, in the opinion of the investigator, places the patient at high risk of treatment-related complications
* No nonhealing wound, peptic ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
* No prior neoadjuvant endocrine therapy
* No prior chemotherapy or radiotherapy
* No major surgical procedure within the past 28 days
* No concurrent full therapeutic dose of anticoagulants or aspirin \> 325 mg/day, clopidogrel \> 75 mg/day, or corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01093235
Study Brief:
Protocol Section:
NCT01093235