Stage IV, HER-2 positive breast cancer patients with brain metastasis and who are eligible for WBRT. MedDRA version: 13.1 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Herceptin
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Patients aged = 18 years; 3. Able to comply with the protocol procedures; 4. Patients with prior histological and/or cytological diagnosis of breast carcinoma with HER-2 over expression (IHC 3+; IHC 2+ and amplified FISH or CISH or SISH) who have first evidence of disease progression to the brain, regardless of control of extracranial disease if present; 5. At least one measurable brain metastasis evaluated with brain contrast MRI; 6. Patients for whom, according to investigator assessment, WBRT is the best therapeutic option; 7. Symptomatic brain lesions and/or brain lesions as the only site of metastatic disease and/or controlled extra-cerebral disease with brain metastases; 8. Patients are eligible regardless of the type and number of prior or concomitant trastuzumab-based therapies received. Patients who received trastuzumab in the adjuvant setting can be included in the study; 9. Performance Status (WHO) = 2; 10. Left ventricular ejection fraction (LVEF) = 50% at baseline (assessed within 2 weeks prior to ICF signature ) as determined by either 2D echocardiogram (ECHO) or MUGA; 11. Prior maximum cumulative dose of doxorubicin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of neoplastic meningitis; 2. Any prior radiotherapy to the brain; 3. Patients with non-controlled extra-cerebral disease who at the time of enrolment, according to investigator judgment, are eligible to a chemotherapy treatment not compatible with the study protocol related timelines; 4. Patients for whom, according to investigator assessment, stereotactic radiotherapy is the best therapeutic option; 5. Previous neoplasm, other than breast carcinoma, within 5 years since the enrolment. Patients with previous diagnosis of in situ carcinoma of the cervix and/or non-melanoma carcinomatous lesions of the skin can be included into the study; 4. Uncontrolled claustrophobia; 5. Uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg); 6. Clinically significant (i.e. active) cardiovascular disease, e.g. cerebrovascular accident (CVA) and myocardial infarction (= 6 months before enrollment), unstable angina, congestive heart failure NYHA class = II, serious cardiac arrhythmia requiring medication during the study which might interfere with regularity of the study treatment, or not controlled by medication; 7. Pregnant or lactating females; 8. For women of childbearing potential (women 16 mg/day). 13. Treatment with chemotherapy and/or lapatinib within 2 weeks prior to ICF signature.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the brain response rate to trastuzumab + WBRT in HER-2 positive breast cancer patients with brain metastases and who are eligible for WBRT (cycle 7).;Secondary Objective: 1. To evaluate brain progression rate at cycle 15 2. To evaluate brain progression free survival (B-PFS) 3. To determine patients’ survival status at the end of the study 4. To evaluate tolerability and safety;Primary end point(s): The primary efficacy endpoint is the brain objective response rate measured at cycle 7. | — |
Countries
Italy
Outcome results
None listed