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:
NCT00030758
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases
* Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following:
* Hospitalization due to neutropenia
* Absolute neutrophil count ≤ 1.5 times upper limit of normal and considered sufficiently low to require a treatment delay or a dose reduction \> 15% of planned dose
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other concurrent malignancy
* Considered suitable risk and fitness status to continue adjuvant chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior filgrastim (G-CSF) or pegfilgrastim
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy other than current regimen
Endocrine therapy:
* Prior tamoxifen allowed
Radiotherapy:
* Concurrent radiotherapy allowed
* No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen)
Surgery:
* See Disease Characteristics
Other:
* Concurrent enrollment on other licensed chemotherapy trials allowed provided G-CSF is not excluded (e.g., TACT or TANGO trials)
* Concurrent enrollment in the sequential arm of the SECRAB trial allowed (synchronous arm ineligible)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00030758
Study Brief:
Protocol Section:
NCT00030758