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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01207102
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically or cytologically confirmed diagnosis of metastatic (Stage IV) breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST);
* "Triple negative" disease defined as "tumor demonstrating no expression for estrogen, progesterone or HER2 receptors." (No expression is categorized as ≤ 10% of cells staining or Allred ≤ 2);
* Aged 18 years or older;
* Eastern Cooperative Oncology Group (ECOG)ECOG/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;
* No prior chemotherapy for metastatic disease.
* At least 6 months must have elapsed since prior adjuvant chemotherapy.
* Laboratory tests performed within 14 days of study entry showing:
* Granulocytes ≥ 1,500/µL;
* Platelets ≥ 100,000/µL;
* Hemoglobin ≥ 9.0 gm/dL;
* Total bilirubin ≤ institutional upper limit of normal (ULN);
* Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN;
* Alkaline phosphatase ≤ 5 times ULN;
* Estimated creatinine clearance ≥ 60 mL/min.
* Urine protein:creatinine ratio ≤ 1.0. or 24 hour urine protein collection demonstrating ≤ 1 gram of protein per 24 hours to be eligible.
* left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (MUGA)/Echocardiogram;
* Informed consent to receive protocol treatment:
* Cognitive and communication skills adequate to comply with study and/or follow-up procedures;
* Geographic proximity and ability to comply with weekly study visits for the duration of the treatment;
* No reproductive potential:
* If pre-menopausal - Negative serum pregnancy test within 3 days prior to initiation of protocol-based treatment and patient agrees to use contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of protocol treatment;
* If post-menopausal - Amenorrhea for ≥ 12 months or follicle stimulating hormone (FSH) within post menopausal range.
Exclusion Criteria:
* Pregnant or breast feeding.
* Prior treatment with Abraxane® or carboplatin.
* Prior chemotherapy for metastatic breast cancer.
* Known hypersensitivity to any component of any study drug.
* Active infection.
* Current neuropathy ≥ grade 2.
* central nervous system (CNS) metastases as determined by head CT with contrast or head MRI.
* Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI), unstable angina, stroke, or transient ischemia within previous 6 months.
* Uncontrolled serious contraindicated medical condition or illness.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01207102
Study Brief:
Protocol Section:
NCT01207102