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:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00546156
Eligibility Criteria:
Inclusion Criteria:
* Documented primary invasive breast cancer by histologic assessment
* Tumors must express estrogen (ER) and/or progesterone receptors (PR) by standard immunohistochemical methods. Tumors must be negative for HER2. There must be sufficient sample for further protocol-specified immunohistochemical analysis
* Patients must have high risk ER+ or PR+ breast cancer as defined by criteria listed in protocol
* 18 year of age or older
* Performance status of 0 or 1 by ECOG criteria
* Use of an effective means of contraception in subjects of childbearing potential
* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting therapy.
* Patients taking exogenous sex-steroid hormone treatments for any reason at the time of diagnosis must discontinue all hormonal treatments at least 2 weeks prior to enrollment
* Patients must have preoperative treatment within 60 days of initial diagnosis of breast cancer
* No other malignancy that requires on-going treatment
* Normal organ function as outlined in the protocol
Exclusion Criteria:
* Prior cytotoxic chemotherapy or radiation for the current breast cancer
* Patients with inflammatory breast cancer
* HER2 positive disease defined as HER2-amplified by FISH or IHC 3+. HER2 2+ must be negative by FISH
* Known metastatic (Stage IV) disease
* Other investigational agents within 4 weeks prior to the start of study treatment
* Life expectancy of less than 6 months
* Peripheral neuropathy greater than or equal to grade 2
* Inadequately controlled hypertension
* Any prior history of hypertensive crisis or hypertensive encephalopathy
* NYHA grade II or greater congestive heart failure
* History of prior myocardial infarction
* History of unstable angina within 12 months prior to study enrollment
* Any history of stroke or transient ischemic attack at any time
* Known CNS disease
* Significant vascular disease
* Symptomatic peripheral vascular disease
* Evidence of significant bleeding within 6 months of study; any serious non-healing wound, skin ulcers, or bone fracture; any abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; any major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during course of study.
* Known HIV positive
* Unwilling to undergo pretreatment biopsy and consent to acquisition of archival tissue
* Pregnant of lactating
* Known hypersensitivity to any component of bevacizumab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00546156
Study Brief:
Protocol Section:
NCT00546156