EUCTR2010-023237-37-DE
Active, not recruiting
Not Applicable
A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab pre-treated patients with HER2-positive metastatic breast cancer - E-VITA
GBG Forschungs GmbH (German Breast Group)0 sites80 target enrollmentOctober 5, 2011
ConditionsMETASTATIC BREAST CANCER in HER2 positiv PatientsMedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsHalaven
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- METASTATIC BREAST CANCER in HER2 positiv Patients
- Sponsor
- GBG Forschungs GmbH (German Breast Group)
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow\-up, must be obtained and documented according to the local regulatory requirements.
- •2\.Complete baseline documentation must be submitted via the web\-based data collection system MedCODES® to the GBG Forschungs GmbH.
- •3\.Histological confirmed carcinoma of the breast with over\-expression of HER2 (IHC3\+ or FISH pos., according to current guidelines of AGO). Every effort should be made to make paraffin embedded tissue or slides from the original tumor and/or from metastatic tissue available for confirmation of diagnosis and additional translational research.
- •4\.Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- •5\.Patients must have either measurable or non\-measurable target lesions according to RECIST criteria. Complete staging work\-up within 4 weeks prior to registration. All patients must have chest X\-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan. In case of positive bone scan, bone X\-ray is mandatory. Other tests may be performed as clinically indicated.
- •6\.The following previous systemic treatments are eligible:
- •Previous treatment with trastuzumab either as (neo)adjuvant treatment for early breast cancer
- •and/or first and/or second line treatment for metastatic breast cancer,
- •adjuvant and up to 2 chemotherapy regimen for metastatic breast cancer,
- •if previous chemotherapy regimen were anthracycline based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m² for doxorubicin and 720 mg/m² for epirubicin,
Exclusion Criteria
- •1\.Known hypersensitivity reaction to the compounds or incorporated substances (e.g. halichondrin B and/or halichondrin B chemical derivative).
- •2\.Patients who have received eribulin or lapatinib before.
- •3\.Concurrent immunotherapy or hormonal therapy (anti\-hormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- •4\.Life expectancy of less than 3 months.
- •5\.Parenchymal brain metastases, unless adequately treated by neurosurgery, radiotherapy, radiosurgery or a combination.
- •6\.Any ongoing toxicity from prior anti\-cancer therapy that is
- •grade \>1 and/or that is progressing in severity, except alopecia or for stable sensory neuropathy Grade 2\.
- •7\.Known or suspected congestive heart failure (\>NYHA I) and/or coronary heart disease, angina pectoris requiring anti\-anginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un\- or poorly controlled arterial hypertension (i.e. BP \>150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
- •8\.Currently active infection.
- •9\.History of other malignancies within the last 5 years which could affect the diagnosis, assessment or prognosis of metastatic breast cancer.
Outcomes
Primary Outcomes
Not specified
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