EUCTR2012-005352-41-IT
Active, not recruiting
Phase 1
A phase II randomized, open-label study evaluating the addition of trastuzumab to (nabTM)-paclitaxel as first line treatment in primary HER2 negative metastatic breast cancer patients with HER2 positive Circulating Tumor Cells (CTCs). - Trastuzumab and (nabTM)-paclitaxel as first line MBC in HER2+ve CTC with primary HER2-ve.
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI CREMONA0 sites86 target enrollmentMarch 7, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer in HER2- positive CTC with primary HER2-negative.
- Sponsor
- AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI CREMONA
- Enrollment
- 86
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed written informed consent.
- •2\.Age \=18 years.
- •3\.ECOG 0\-2
- •4\.At least one clinically or radiologically measurable lesion and/or non\-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors (RECIST version 1\.1\). Osteoblastic/osteolytic bone metastasis will be included.
- •5\.HER2 negative on primary tumor (HER\-2 score of 0 or 1\+/2\+ with FISH not amplified) as locally diagnosed.
- •6\.Detection of at least 1 HER2\+ve CTC.
- •7\.Patients may have received chemotherapy/hormonotherapy as neo/adjuvant treatment.
- •8\.Adequate bone marrow, renal and hepatic functions: ANC greater than 1\.5x10^9/l, platelets greater than 100x10^9/l, serum creatinine \< 1\.5 x UNL, serum AST/ALT \< 1\.5 x UNL unless liver metastasis \< 2\.5 x UNL.
- •9\.Adequate cardiac function: left ventricular ejection fraction (LVEF) at rest measured by echocardiography or MUGA scan must be no lower than the local normal limit.
- •10\.Troponin level below the cut\-off.
Exclusion Criteria
- •1\.Previous chemotherapy or hormonotherapy for metastatic disease
- •2\.Any psychiatric disorder that would impair the understanding and giving of informed consent.
- •3\.Male patients
- •4\.Non evaluable lesions as ascitic, pleural and pericardial effusions, carcinomatous lymphangitis of the lung, meningeal involvement.
- •5\.Pregnant or lactating patients.
- •6\.History of atrial ventricular arrhythmia, congestive heart failure or angina pectoris, even if medically controlled; uncontrolled hypertension; history of 2nd or 3rd degree heart blocks.
- •7\.Any history of a second neoplasm except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •8\.Concomitant treatment with other anticancer drugs.
- •9\.Concomitant treatment with any other experimental drug.
- •10\.Patients with not adequate haematological, hepatic and renal function.
Outcomes
Primary Outcomes
Not specified
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