Clinical Trial Details
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NCT01924351 : HER2-positive Breast Cancer With Brain Metastasis (GCC 1345)
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically proven diagnosis HER2-positive breast cancer. Her2-positive is defined
as follows:

* Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of
invasive tumor cells)

- OR- Average HER2 gene copy number of >6

- OR- Gene amplified (HER2:D17Z1 ratio >2.20).

- Patients with 1-10 newly diagnosed brain metastases

- The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and
must have a maximum diameter of ? 4.0 cm in any direction on the enhanced scan. If
multiple lesions are present and one lesion is at the maximum diameter, the other(s)
must not exceed 3.0 cm in maximum diameter.

- History and physical with neurological examination, steroid documentation, height,
and weight within 14 days of registration.

- A diagnostic contrast-enhanced MRI of the brain must be performed within 28 days
prior to registration.

- Eligibility for treatment with SRS confirmed by a radiation oncologist.

- Performance Status 0-2

- Age ? 18.

- CBC with differential obtained within 14 days prior to registration, with adequate
bone marrow function defined as follows:

- Absolute neutrophil count (ANC) ? 1,100 cells/mm3.

- Platelets ? 75,000 cells/mm3.

- Hemoglobin ? 9.0 g/dl (Note: The use of transfusion or other intervention to achieve
Hgb ?9.0 g/dl is acceptable).

- Adequate renal function within 14 days prior to registration, as defined below:

- BUN ? 30 mg/dl.

- Creatinine ? 1.5 x ULN

- Creatinine clearance ?30 mL/min.

Adequate hepatic function within 14 days prior to registration, as defined below:

- Total Bilirubin ?1.5 x ULN

- ALT/AST ? 2.5 x upper limit of normal (ULN).

- Systolic blood pressure ? 160 mg Hg or diastolic pressure ? 90 mg Hg within 14 days
prior to registration.

- Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on
warfarin confirmed by testing within 14 days prior to registration. Patients on
full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the
following criteria:

- No active bleeding or pathological condition that carries a high risk of bleeding
(e.g., tumor involving major vessels or known varices).

- In-range INR (between 2.5 and 3.5) on a stable dose of warfarin-based oral
anticoagulant; or on a stable dose of low molecular weight heparin; or INR between
1.5 and 2 if a Greenfield filter is in place.

- Patient must provide study specific informed consent prior to study entry.

- For women of child-bearing potential, negative serum pregnancy test within 14 days
prior to registration.

- Women of childbearing potential and male participants must practice adequate

- Echocardiogram or MUGA scan with ejection fraction within normal institution limits
within 28 days of registration

Exclusion Criteria:

- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease
free for ? 3 years. For example, carcinoma in situ of the oral cavity and cervix are
all permissible.

- Leptomeningeal metastases

- Previous treatment with all of the following: lapatinib, trastuzumab, pertuzumab, and
trastuzumab emtansine. (Patients are eligible if treated with 3 or less of these

- Prior cranial radiotherapy.

- Prior resection of cerebral metastases

- Allergy to gadolinium

Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure within the last 6 months.

- Transmural myocardial infarction within the last 6 months.

- New York Heart Association grade II or greater congestive heart failure requiring
hospitalization within 12 months prior to registration.

- History of stroke, cerebral vascular accident (CVA) or transient ischemic attack
within 6 months.

- Serious and inadequately controlled cardiac arrhythmia.

- Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or
clinically significant peripheral vascular disease.

- Evidence of bleeding diathesis or coagulopathy.

- Serious or non-healing wound, ulcer, or bone fracture or history of abdominal
fistula, gastrointestinal perforation or intra-abdominal abscess, major surgical
procedure or significant traumatic injury within 28 days prior to registration, with
the exception of the craniotomy for tumor resection or follow-on craniotomies to
manage complications of brain tumor management such as hemorrhage or infection.

- Bacterial or fungal infection requiring intravenous antibiotics at the time of

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration.

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for coagulation parameters are not required for
entry into this protocol.

- Active connective tissue disorders, such as lupus or scleroderma, that in the opinion
of the treating physician may put the patient at high risk for radiation toxicity.

- Any other major medical illnesses or psychiatric impairments that in the
investigator's opinion will prevent administration or completion of protocol therapy.

- Cognitive impairment that precludes a patient from acting as his or her own agent to
provide informed consent.

- Women of childbearing potential who are sexually active and not willing/able to use
medically acceptable forms of contraception; this exclusion is necessary because the
chemotherapeutic treatment involved in this study is potentially teratogenic.

- Pregnant or lactating women, due to possible adverse effects on the developing fetus
or infant due to study treatment.

- Patients treated on any other therapeutic clinical protocols within 30 days prior to
study entry or during participation in the study.

- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a

- Inability to undergo SRS due to claustrophobia
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