Clinical Trial Details
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NCT01921335 : ARRY-380 + Trastuzuamab for Breast w/ Brain Mets
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Participants must meet the following criteria on screening examination to be eligible
to participate in the study. Laboratory evaluations must have been performed within
14 days of study entry. Non-laboratory tests must have been performed within 30 days
of study entry. Evaluation of LVEF must have been performed within 60 days of study

- Participants must have histologically confirmed HER2+ (3+ by immunohistochemistry
and/or FISH ratio >/= 2.0) invasive breast cancer. Central confirmation of HER2
status is not required.

- Participants must have measurable CNS disease, defined as at least one parenchymal
brain lesion that can be accurately measured in at least one dimension (longest
diameter to be recorded) as > 10 mm by local radiology review (note: measurable
non-CNS disease is NOT required for study participation). See section 10 for the
evaluation of measureable disease.

- New or progressive CNS lesions, as assessed by the patient's treating physician.

- It is anticipated that some participants may have multiple progressive CNS lesions,
one or several of which are treated with SRS or surgery with residual un-treated
lesions remaining. Such participants are eligible for enrollment on this study
providing that at least one untreated lesion is measurable, as defined in section
3.1.2. The location of the measurable lesion should be documented in the patient
chart and case report form.

- Participants who have had prior cranial surgery are eligible, provided that there is
evidence of measurable residual or progressive lesions. If a patient has surgical
resection followed by WBRT, then there must be evidence of progressive CNS disease
after the completion of WBRT.

- Participants who have had prior WBRT and/or SRS and then whose lesions have
progressed thereafter are also eligible. In this case, lesions which have been
treated with SRS may be considered as target lesions if there is unequivocal
evidence, in the opinion of the treating physician, of progression following SRS.

- Participants who have not previously been treated with cranial radiation (e.g. WBRT
or SRS) are eligible to enter the study, but such participants must be asymptomatic
from their CNS metastases and not requiring corticosteroids.

- No increase in corticosteroid dose in the week prior to the baseline brain MRI.

- Age ?18 years

- ECOG performance status 0 to 2 (see Appendix A)

- Participants must have normal organ and marrow function as defined below:

- Absolute neutrophil count ? 1,000/mcL

- Platelets ? 75,000/mcL

- Total bilirubin < 2 X institutional upper limit of normal

- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal in participants
without liver metastases and < 5 ULN in participants with documented liver metastases

- Left ventricular ejection fraction ? 50%, as determined by RVG or echocardiogram
within 60 days prior to initiation of protocol therapy

- Prior therapy - Prior trastuzumab and/or lapatinib are allowed. There is no limit on
the number of prior lines of therapy.

- The effects of ARRY-380 on the developing human fetus are unknown. For this reason
and because other therapeutic agents used in this trial may be teratogenic, women of
child-bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Participants who exhibit any of the following conditions at screening will not be
eligible for admission into the study.

- Participants who have had chemotherapy or radiotherapy within 14 days prior to
entering the study (with the exception of trastuzumab) or those who have not
recovered from adverse events to ? grade 1 due to agents administered more than 4
weeks earlier.

- Participants may not be receiving any other investigational agents. Concurrent
treatment with bisphosphonates or denosumab is allowed

- History of grade 3 or 4 allergic reactions attributed to compounds of similar
chemical or biologic composition to ARRY-380 or trastuzumab

- Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker,
shrapnel, or ocular foreign body

- Leptomeningeal carcinomatosis as the only site of CNS involvement

- More than 2 seizures over the last 4 weeks prior to study entry

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnancy (positive pregnancy test) or lactation

- Individuals with a history of a different active malignancy are ineligible.
Participants with a history of other malignancies are eligible if they have been
disease-free for at least 2 years, not on active treatment, and deemed by the
investigator to be at low risk for recurrence of that malignancy. Individuals with
the following cancers are eligible if diagnosed and treated within the past 2 years:
cervical cancer in situ, basal cell or squamous cell carcinoma of the skin.
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