Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease not amenable to any local treatment with curative intent.
HER2-positive by FISH, CISH, or IHC 3+
ECOG performance status 0 or 1
Left ventricular ejection fraction greater than or equal to institutional lower limit of normal
Adequate laboratory studies (hematological, chemistries and urinalysis)
Life expectancy greater than or equal to 3 months
Cohort A only:
Trastuzumab naïve or trastuzumab in the neo-adjuvant setting
No clinically significant drop in cardiac function prior exposure to trastuzumab
No prior chemotherapy for metastatic or locally recurrent breast cancer
No prior lapatinib therapy
At least 3 weeks from enrollment since prior chemotherapeutic agents, including taxanes, in the neoadjuvant or adjuvant setting
At least 3 months from enrollment since prior trastuzumab in the neoadjuvant or adjuvant setting
Cohort B only:
Must have failed trastuzumab in the first-line metastatic setting. Trastuzumab must be discontinued for at least 3 weeks prior to enrollment
Must have received prior chemotherapy as adjuvant therapy or for metastatic disease
Prior chemotherapy treatment must be discontinued for at least 3 weeks prior to enrollment
No prior capecitabine
No prior lapatinib
You may not be if
Inflammatory breast cancer
Central nervous system metastasis
Clinically significant cardiovascular disease
Radiation therapy ≤ 14 days prior to enrollment.
Concurrent anticoagulation therapy, excluding aspirin, anti-platelet agents, low molecular weight heparin or low dose warfarin per protocol.
Uncontrolled hypertension defined as diastolic blood pressure \> 90 mmHg OR systolic blood pressure \> 140 mmHg.
Subjects with a history of prior malignancy, except:
For Cohort B only:
Current or prior history of long QT syndrome
Baseline ECG report of QTc interval of \> 480 milliseconds
Severe chronic liver disease (Child Pugh C)
Clareo Health | Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
