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RTOG 1119   |   13-551
Phase II Randomized study of whole brain radiotherapy in combination with concurrent lapatinib in patients with brain metastasis from HER2-Positive Breast cancer. A collaborative study of RTOG and KROG.

Disease(s)
Brain
Breast
Hospital(s)
Beachwood
Fairview
Hillcrest
Independence
North Coast Cancer
Strongsville
Wooster
Phase(s)
Phase 2
Stage(s)
Type(s)
Therapeutic
Drug(s)
Lapatinib

Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description
Primary
  1. To determine if there is a signal for an increase in complete response (CR) rate in the brain at 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.
Secondary
  1. To evaluate CR rate in the brain at 4 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.
  2. To evaluate objective response rate in the brain at 4 and 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.
  3. To evaluate lesion-specific objective response rate (CR + PR) at 4 and 12 weeks post WBRT.
  4. To evaluate overall response with addition of lapatinib to WBRT compared to WBRT alone.
  5. To evaluate the CNS progression-free survival (CNS PFS) rate and overall survival (OS) rate, with the addition of lapatinib to WBRT compared to WBRT alone.
  6. To evaluate treatment related adverse events when adding lapatinib to WBRT compared to WBRT alone.

Inclusion Criteria
  1. Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
  2. HER2 overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by FISH or SISH ≥ 2.2)
  3. At least 1 measurable, unirradiated parenchymal brain lesion (≥ 10 mm on T1-weighted gadolinium enhanced MRI) within 21 days prior to study entry:
    1. Progressive parenchymal brain metastases following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable lesion
    2. Progressive parenchymal brain metastases following surgical resection of 1-3 brain metastases, as long as at least 1 brain metastasis is measurable
  4. History/physical examination within 21 days prior to study entry
  5. Karnofsky performance status ≥ 60 within 21 days prior to study entry
  6. Age ≥ 18
  7. Able to swallow and retain oral medication (Note, for patients unable to swallow tablets, an oral suspension preparation is acceptable, per Section 7.2.10)
  8. Adequate hematologic, renal, hepatic function within 21 days prior to study entry, as defined by the following:
    1. Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3
    2. Platelets ≥ 70,000 cells/mm3
    3. Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
    4. Creatinine < 1.5 times institutional upper limit of normal
    5. Bilirubin < 1.5 times institutional upper limit of normal
    6. AST and ALT ≤ 3.0 times institutional upper limit of normal with or without liver metastasis
  9. At least 14 days between FINAL dose of prior chemotherapy and study entry, with recovery of toxicities to grade 0 or 1
  10. Patient must provide study specific informed consent prior to study entry
  11. Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry
  12. Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion

Exclusion Criteria
  1. Prior WBRT
  2. Prior lapatinib therapy
  3. 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
  4. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  5. Leptomeningeal disease
  6. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion
  7. Severe, active co-morbidity, defined as follows:
    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    2. Transmural myocardial infarction within the last 6 months
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
    4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
    5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
    6. History of LVEF below institutional normal unless repeated and within institutional normal range within 90 days of study entry
  8. Grade 2 or greater rash of any cause at time of study entry
  9. Grade 2 or greater diarrhea of any cause at time of study entry

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