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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01525966
Eligibility Criteria:
Inclusion Criteria:
* Patients must be diagnosed with locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory triple negative breast cancer
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* Tumor negative for expression of hormone receptors (\< 10%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testing
* Bilirubin =\< 1.5 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal
* Alkaline phosphatase =\< 2 x upper limit of normal
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin \> 9.0 g/dL
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
* Creatinine =\< 1.5 mg/dL is recommended; however, institutional norms are acceptable
* Left ventricular ejection fraction \> 50%
* Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
* Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test screening for patients of childbearing potential
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* No prior therapies are allowed for the treatment of the newly diagnosed breast cancer; patients with a prior diagnosis of malignancy treated \>= 5 years ago are eligible, provided that they have not received prior taxanes or carboplatin as part of their prior treatment regimen, and that they meet all eligibility criteria
Exclusion Criteria:
* Known active hepatitis B or C
* Known active human immunodeficiency virus (HIV)
* Prior breast cancer or other invasive malignancy treated within 5 years
* Pregnancy
* Neuropathy \> grade 1
* Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/primary investigator (PI)
* Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT01525966
Study Brief:
Protocol Section:
NCT01525966