Status:
COMPLETED
Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients
Lead Sponsor:
UNICANCER
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * Evaluate the complete histological response rate in patients with inflammatory HER2-negative breast cancer treated with bevacizumab and concurrent chemotherapy followed by beva...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed inflammatory breast cancer, meeting 1 of the following staging criteria:
- T4d, any N (AJCC stage IIIB or IIIC)
- Gustave-Roussy Institute (IGR) classification Poussee evolutirie (PEV; measures tumor growth over time) 2
- PEV 2: tumor with underlying breast tissue, especially skin, that is affected by subacute inflammation and edema involving \< ½ of breast surface
- IGR classification PEV 3
- PEV 3: acute or subacute inflammation and edema involving \> ½ of breast surface
- Biopsy-confirmed presence of tumor embolism in surface lymph nodes
- HER2-negative (HER2 0 or 1+, or HER2 2+ by IHC if FISH-negative allowed)
- No metastatic disease
- No non-inflammatory breast cancer with edema, ulceration, or satellite skin nodules
- No bilateral breast cancer
- Hormone receptor status known
- PATIENT CHARACTERISTICS:
- Any menopausal status allowed
- WHO performance status 0-2
- Life expectancy ≥3 months
- LVEF normal by ECHO
- ANC \>1.5 x 10\^9/L
- Platelet count \>100 x 10\^9/L
- INR ≤1.5 (except for patients on prophylactic anticoagulants)
- aPTT ≤1.5 times upper limit of normal (ULN)
- Total bilirubin normal
- SGOT and SGPT ≤1.25 times ULN
- Alkaline phosphatase ≤2.5 times ULN
- Creatinine clearance ≥60 mL/min
- Proteinuria \<2+ or 24-hour urine protein ≤1 g
- No unhealed wound, stomach ulcer, or bone fracture
- No history of thrombotic or hemorrhagic disorders
- No significant cardiovascular disease including the following:
- Cerebrovascular accident within the past 6 months
- Unstable angina
- Cardiac failure
- Myocardial infarction
- Arrhythmia requiring treatment
- No uncontrolled hypertension (i.e., systolic BP \>150 mm Hg and/or diastolic BP \>100 mm Hg)
- No other active infection or serious illness that would preclude patient from receiving study treatment
- No hypersensitivity to any active products or excipients of study drugs
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No social or psychologic reasons that would prevent study compliance or follow-up
- No patients who are incarcerated or on probation
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or hormonal therapy for this disease
- More than 4 weeks since prior surgery (diagnostic biopsy or installation of implant allowed)
- More than 10 days since prior chronic non-inflammatory steroids (e.g., acetylsalicylic acid \>325 mg/day) or platelet anticoagulation treatment (e.g., dipyridamole, ticlopidine, clodiprogel, cilostazol)
- More than 10 days since prior oral or parenteral anticoagulant or thrombolytic drugs (preventative thrombolytic drugs allowed)
- No concurrent participation in another experimental clinical trial
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00820547
Start Date
January 1 2009
End Date
September 1 2019
Last Update
October 22 2019
Active Locations (28)
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1
Centre Paul Papin
Angers, France, 49036
2
Institut Sainte Catherine
Avignon, France, 84000
3
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France, 25030
4
Institut Bergonie
Bordeaux, France, 33076