neoadjuvant treatment of patients with primary breast cancer and no distant metastases
Conditions
Sponsors
Roche Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Female patients with histologic proven, core-biopsied, invasive breast cancer of any clinical and/or radiological T-stage (except T4d =inflammatory breast cancer) scheduled to receive preoperative chemotherapy. ? Age 18-70 years ? ECOG performance-status 13 g/dl (b) Hepatic function : Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Stage T4d/ inflammatory breast cancer ? Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation ? Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by WHO criteria ? Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy) ? Prior or concurrent systemic antitumor therapy ? Evidence of wound healing complications, bone fracture, ulcer or the presence of clinically significant peripheral vascular disease ? Clinically significant cardiac disease e.g. congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrythmias ? Other serious illness or medical condition - history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent - active uncontrolled infection - unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids ? Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, inhalational use, treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose ( 325mg / day) or other medications known to predispose to gastrointestinal ulceration. ? Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0 (patient must have recovered from any major injury), or anticipation of need for major surgical procedure during the course of the study. ? Treatment with an investigational drug within 30 days prior to study entry. ? Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study. ? Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of Avastin. Pathologic complete response rate will be measured. ;Secondary Objective: To evaluate the safety and toxicity of Avastin in combination with Docetaxel and Capecitabine given as preoperative therapy to breast cancer patients. Clinical objective response rate and rate of breast- conserving surgery will be measured. ;Primary end point(s): Pathologic complete response rate | — |
Countries
Austria
Outcome results
None listed