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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02217033
Eligibility Criteria:
Inclusion Criteria:
* Female, non-smokers ≥ 18 years of age
* Histologically or cytologically confirmed diagnosis of Stage I or II adenocarcinoma of the breast and a candidate for adjuvant chemotherapy
* Scheduled to receive 4 cycles of adjuvant Taxotere and Cytoxan chemotherapy (TC): docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on Day 1 of each 21-day cycle
* Eastern Cooperative Oncology Group Status (ECOG) performance status of ≤ 1
* No prior treatment for breast cancer other than surgery
* Adequate baseline organ function as evidenced by:
* Hemoglobin ≥ 9 g/dL
* Absolute neutrophil count ≥ 1.5 x 109 cells/mm3
* Platelet count ≥ 100,000 cells/mm3
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
* Alkaline phosphatase ≤ 1.5 x ULN
* No history of other malignancies within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma or squamous cell carcinoma of the skin that have been previously treated with curative intent
* Women of childbearing potential who commit to using two forms of highly effective non-hormonal contraception either by the subject and/or partner during the study
* Negative urine pregnancy test at screening
* Negative urine drug screen (UDS) for drugs of abuse including cotinine (nicotine) at screening
* Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent
Exclusion Criteria:
* Preexisting diagnosed psychiatric disorder as defined by The Diagnostic and Statistical Manual (DSM) of Mental Disorders (published by the American Psychiatric Association). Subjects with a diagnosis of depression will be allowed to enter into study as long as they have been treated with medication for ≥ 6 months and/or depression is considered to be well controlled
* Pregnant or lactating
* Diabetes
* Concomitant use of any sleeping agents during the course of the study (Anti- anxiety medications will be allowed)
* Steroid therapy other than the standard prescribed therapy of either of the following during the course of the study:
* Dexamethasone 4-12 mg IV on Day 1 of any cycle
* Dexamethasone 4-12 mg PO on Day 2 and Day 3 of any cycle
* Anti-estrogen therapy other than the standard prescribed therapy of one of the following:
* Tamoxifen/Nolvadex 20 mg PO daily
* Anastrazole/Arimidex 1 mg PO daily
* Letrozole/Femara 2.5 mg PO daily
* Exemestane/Aromasin 25 mg PO daily
* Use of any other antiemetic regimen other than the following (with the exception of PO antiemetics):
* Emend /Aprepitant150 mg IV on Day 1 of any cycle
* Aloxi/Palonosetron 0.25 mg IV on Day 1 of any cycle
* Dexamethasone 8 mg IV on Day 1 of any cycle
* Dexamethasone 8 mg PO on Day 2 and Day 3 of any cycle
* Zofran/Ondansetron 12 mg IV on Day 1 of any cycle
* Kytrile/Granisetron 1-2 mg IV on Day 1 of any cycle
* Therapy with any immunomodulatory or immunosuppressive drugs within 6 months prior to enrollment
* Known history of positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody
* Any change in the initially prescribed chemotherapy
* Use of herbal remedies, dietary supplements or mega-vitamins, with the exception of a multi-vitamin
* Investigator deems the subject to be unable or unwilling to comply with the requirements of the protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02217033
Study Brief:
Protocol Section:
NCT02217033