Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medstar Health Research Institute
With
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Females or males with histologic confirmation of breast carcinoma and diagnosis of metastatic breast adenocarcinoma
Confirmed HER2 amplification by immunohistochemical staining (IHC) 3+ or FISH amplified (either primary or metastatic).
Have had any number of prior HER2 targeted therapy containing chemotherapies for treatment of breast cancer
Measurable extent of disease
Life expectancy of 3 months or greater
Patients must have adequate heart function, determined with ECHO or MUGA (ECHO preferred).
Patients must have adequate bone marrow and organ function
Patient of childbearing potential must be willing to use an effective means of contraception during their participation on trial
Greater than 3 weeks from prior radiation or chemotherapy; more than 1 week from prior hormonal therapy; and more than 6 weeks from prior treatment with nitrosoureas or mitomycin.
No serious intercurrent medical illness.
Controlled metastatic CNS disease ≥ 3 months
The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol.
You may not be if
Pregnant or nursing women
Patients who are poor medical risk because of other non-malignant systemic disease or active, uncontrolled infection.
Prior craniospinal radiation, or total body irradiation (TBI).
Patients receiving G-CSF (filgrastim or pegfilgrastim) or thrombopoietin (or other platelet growth factors) within the 3 weeks prior to enrollment (erythropoietin is allowed).
Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin).
Prior radiation therapy within the last 3 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).
Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Current symptoms of angina or uncontrolled arrhythmias, uncontrolled hypertension with systolic blood pressure \>=170 or diastolic blood pressure \>=110.
Psychiatric illness precluding participation in study
Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest.
Carcinomatous meningitis or CNS mets not controlled for ≥ 3 months.
