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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01649258
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Projected life expectancy of at least 3 months
* Provision of informed consent prior to any study-related procedures
* Negative pregnancy test for women of childbearing potential
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 100,000 cells/mm\^3
* Hemoglobin \>= 9.0g/dL
* Serum creatinine =\< 1.5 mg/dl
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 X upper limit of normal (ULN)
* Alkaline phosphatase =\< 2.5 X upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =\< upper limit of normal an alkaline phosphatase =\< 5 ULN will be allowed
* Serum bilirubin =\< 1.0 mg/dL
* No other concomitant therapy directed at the cancer is allowed
Exclusion Criteria:
* Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone
* Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
* Use of anticoagulant agent (Warfarin, Coumadin, Jantoven, Marevan, Lawarin, Waran, or Warfant)
* An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
* Severe concurrent illness other than neoplasia
* Gastrointestinal obstruction or an active peptic ulcer
* Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01649258
Study Brief:
Protocol Section:
NCT01649258