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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02124902
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed AJCC7 clinical stage II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal.
* Patients with PR+ tumors are allowed.
* HER2 negative by FISH or IHC staining 0 or 1+.
* ER less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor
* Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO criteria). Patients with palpable lymph nodes may be enrolled regardless of tumor size.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Normal bone marrow and organ function as defined below:
* Leukocytes ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcl
* Platelets ≥ 100,000/mcl
* Serum bilirubin within (or under ) normal limits (OR total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
* AST(SGOT)/ALT(SGPT) within (or under ) normal limits
* Creatinine clearance ≥ 60 mL/min/1.73 m2
* Patients may be pre- or post-menopausal. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
* Able to tolerate PET/MRI with intravenous contrast administration and must complete the applicable MRI screening evaluation form
Exclusion Criteria:
* Prior systemic therapy for the indexed breast cancer.
* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
* Patients with bilateral or inflammatory breast cancer.
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test within 7 days of study entry if premenopausal.
* Known HIV-positivity.
* Sentinel lymph node biopsy
* Renal insufficiency (glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2) measured within the past 60 days which precludes safe administration of the contrast agent
* On dialysis
* Prior allergic reaction to gadolinium-based MR contrast agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02124902
Study Brief:
Protocol Section:
NCT02124902