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 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT00121134
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
* Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.
* Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.
* For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.
* Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.
* LVEF \> institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.
* ECOG performance status 0-1
Exclusion Criteria:
* Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment
* Patients with metastatic disease are ineligible.
* Known HIV infection
* Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding
* Uncontrolled intercurrent illness
* Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment
* History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab
* Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded
* History of bleeding diathesis or coagulopathy
* History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)
* Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer
* Patients with large or rapidly accumulating pleural or abdominal effusions
* Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR
* Chronic therapy with full dose aspirin (\< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed
* Patients may not receive other investigational agents while on study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00121134
Study Brief:
Protocol Section:
NCT00121134