HER2-positive Breast Cancer With Brain Metastasis (GCC 1345)

Withdrawn before enrolling · Phase 2

Conditions studied: Breast Cancer With Brain Metastasis

In brief

Primary Objective: To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%. Secondary Objectives: 1. Describe the natural history of neurocognitive function for women with brain metastases treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark to generate hypothesis for future design of a phase III trial. 2. Describe patterns of distant brain relapse after SRS for all patients and compare them between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated with each systemic therapy regimen 3. Describe patterns of neurologic death 4. Describe patterns of local brain relapse 5. Describe patterns of re-irradiation with WBRT or SRS 6. Describe adverse events

Key facts

Study ID

NCT01924351

Run by

University of Maryland, Baltimore

People needed

0

Starts

2015-02-01

Expected to finish

2016-06-01

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 agents.)
• 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 registration.
• 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 pacemaker).

Where it is running

• Ummc Msgcc — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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