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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00270894
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant females =/\> 18 years of age
* Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
* Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
* Normal cardiac function and adequate hematologic function
* Human epidermal growth factor receptor 2 protein (HER2) positive
* No evidence of metastatic disease
* ECOG Performance Status 0 - 1
* Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
Exclusion Criteria:
* Treated with other investigational drugs within 30 days
* Uncontrolled intercurrent disease or active infection
* Known sensitivity to e. coli-derived proteins or polysorbate 80
* Psychiatric illness or social situation that would limit study compliance
* Pre-existing peripheral neuropathy \> Grade 1
* Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
* Bilateral synchronous breast cancer
* Inflammatory breast cancer
* Women who are pregnant or breast feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00270894
Study Brief:
Protocol Section:
NCT00270894