locally advanced or recurrent breast cancer with lymphangitic spread to the chest wall. MedDRA version: 9.1 Level: LLT Classification code 10006279 Term: Breast neoplasm
Conditions
Interventions
Trade Name: AVASTIN*INFUS 1FL 400MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven locally advanced breast cancer (with or without metastases) accessible for biopsy with lymphangitic spread to the chest wall and to the skin, who have or have not been treated with chemotherapy or radiation therapy may be eligible for this study. Inflammatory breast cancer, defined as histologically proven invasive adenocarcinoma of one breast with clinical inflammatory signs including onset of erythema and brawny induration or edema of the skin with an erysipeloid edge with or without an underlying tumor mass; dermal lymphatic involvement by tumor cells is not a requirement for diagnosis. Patients with lymphangitic cutaneous metastases (with or without evidence of primary tumor) are eligible for the study. 2. Patients must have tissue accessible for serial biopsies. 3. Expected survival of > 3 months. 4. Karnofsky performance status > 70%, or Eastern Cooperative Oncology Group/ Swiss Group for Clinical Cancer Research (ECOG/SAKK) performance status 0-1. 5. Within 2 weeks prior to study day 1, vital laboratory parameters within normal range, except for specified limits listed below: Neutrophil count >= 2.0 x 109/L Lymphocyte count >= 0.5 x 109/L Platelet count >= 100 x 109/L Serum creatinine = 18 years 7. Able to give valid written informed consent. 8. Negative stool guaiac test (read by laboratory). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Candidate to endocrine or trastuzumab therapy. 2. Brain metastases documented by CT or MRI scan 3. Previous capecitabine or vinorelbine treatment < 6 months prior to study entry, or on primary progression on previous capecitabine or vinorelbine treatment (either intravenous or oral) 4. Patients with non-healing wounds, bone fractures, or major surgery within the previous 28 days 5. Uncontrolled hypertension (sustained systolic blood pressure greater than 160 mmHg or diastolic blood pressure of greater than 100 mmHg). 6. INR greater than 1.50. Prior history of bleeding diathesis or coagulopathy including deep venous thrombosis or pulmonary embolism. 7. Recent (within last six months) or current history of gastrointestinal bleeding. 8. Current use of full-dose or parenteral anticoagulants or chronic daily treatment with aspirin (greater than 325 mg/day) within 10 days prior to Day 1 on study. 9. Active infection requiring intravenous antibiotics on Day 1 on study. 10. Patients with 24 hour urine protein greater than or equal to 500 mg or any active primary renal disease (excluding infection). 11. Clinical grade greater than or equal to 2 peripheral neuropathy. 12. History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications. 13. Pregnant or lactating women. 14. Patients who are receiving other investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: safety evalution of intravenous bevacizumab with sequential versus concurrent oral vinorelbine plus capecitabine in patients with locally advanced or recurrent breast cancer;Secondary Objective: efficacy in terms of survival as well as anti-angiogenic activity;Primary end point(s): tolerability of bevacizumab administration alone or in combination with vinorelbine and capecitabine | — |
Countries
Italy
Outcome results
None listed