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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02413320
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed stage I (T\>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy
* The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry.
* HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing
* No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer
* Female subjects age 18 - 70 years
* ECOG Performance Status of 0-1
* Adequate organ and marrow function as defined below:
* Leukocytes ≥ 3,000/uL
* Absolute neutrophil count ≥ 1500/uL
* Platelets ≥ 100,000/uL
* Total bilirubin ≤ 1.5mg/dL
* AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal
* Creatinine ≤ 1.5mg/dl and/or Creatinine Clearance ≥ 60mL/min
* Serum albumin ≥ 3.0 g/dL
* Women of child-bearing potential must agree to use adequate contraception
* Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration
* Subjects should have LVEF ≥ 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation
* Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation
* Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.
* Subjects must be already enrolled in P.R.O.G.E.C.T observational registry
* Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease
* Subjects with bilateral disease are eligible if they meet other eligibility criteria.
* Neuropathy: No baseline neuropathy grade \> 2
Exclusion Criteria:
* Current or anticipated use of other investigational agents
* Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer
* Subject with metastatic disease
* History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study
* Subjects with inflammatory breast cancer
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
* Subject is pregnant or nursing
* Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
* Ejection Fraction \<50% on ECHO or MUGA
* Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP\>160 or Diastolic BP\>90), uncontrolled or symptomatic arrhythmia, or grade ≥ 2 peripheral vascular disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02413320
Study Brief:
Protocol Section:
NCT02413320