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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT00824733
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Locally advanced or metastatic disease
* HER2-overexpressing tumor, defined as 3+ overexpression by IHC and/or HER2 amplified by FISH
* Non-measurable disease allowed
* Achieved partial response, complete response, or stable disease (i.e., no disease progression for ≥ 12 weeks) while on trastuzumab (Herceptin®) and chemotherapy, hormonal therapy alone, or trastuzumab alone
* Last dose of trastuzumab must have been administered within the past 16 weeks
* No unstable brain metastases
* Patients with brain metastases are eligible provided they have been stable for ≥ 1 month after surgery or radiotherapy/radiosurgery AND off corticosteroids and anticonvulsants for ≥ 4 weeks
* Hormone receptor status unspecified
PATIENT CHARACTERISTICS:
* ECOG(Eastern Cooperative Oncology Group)performance status (PS) 0-2 (Karnofsky PS 70-100%)
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin \> 8 g/dL (transfusion/epoetin alfa allowed)
* Platelet count ≥ 100,000/mm³
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if known liver metastases)
* Creatinine \< 2 mg/mL
* Ejection fraction ≥ 50% by echocardiogram or MUGA
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study treatment
* No ongoing or active infection requiring oral or IV antibiotics
* No known autoimmune disorders or antibody-mediated disorders
* No known HIV positivity
* No known history of hepatitis B or C (active and/or previously treated)
* No other malignancies within the past 5 years except nonmelanoma skin cancer or cervical cancer in situ
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 12 weeks since prior chloroquine
* More than 4 weeks since prior growth factors
* More than 4 weeks since prior systemic corticosteroids
* More than 4 weeks since prior chemotherapy, radiotherapy, or monoclonal antibody therapy (except trastuzumab)
* No prior agatolimod sodium
* No prior allogeneic stem cell transplantation
* No prior continuous treatment with single-agent trastuzumab for \> 6 months
* No more than 3 prior chemotherapy regimens for metastatic breast cancer
* Any number of prior hormonal therapies allowed
* No other concurrent investigational agents or monoclonal antibodies
* No other concurrent anticancer agents or therapies
* Concurrent bisphosphonates for skeletal metastasis allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00824733
Study Brief:
Protocol Section:
NCT00824733