Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Biological: bevacizumab
- Registration Number
- NCT00820547
- Lead Sponsor
- UNICANCER
- 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 carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.
- 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 bevacizumab and concurrent hormonal therapy after surgery and radiotherapy.
Secondary
* Evaluate the progression-fee and overall survival of these patients at 3 and 5 years.
* Evaluate the tolerance of bevacizumab in these patients.
* Assess circulating metastatic disease before, during, and after treatment.
* Assess circulating endothelial cells before, during, and after treatment.
* Assess predictive factors of response by genomic and proteomic studies on frozen tumor samples and fluid samples (i.e., serum and plasma).
OUTLINE: This is a multicenter study.
* Neoadjuvant induction therapy:
* Courses 1-4: Patients receive bevacizumab IV over 30-90 minutes, fluorouracil IV, epirubicin hydrochloride IV over 10 minutes, and cyclophosphamide IV over 5 minutes on day 1.
* Courses 5-8: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 1 hour on day 1.
Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
* Surgery: Patients undergo surgery 4-6 weeks after completion of bevacizumab.
* Adjuvant therapy: Beginning 2-4 weeks after surgery, patients undergo radiotherapy for 6 weeks. Patients also receive bevacizumab IV over 30-90 minutes beginning 2-4 weeks after surgery, during the radiotherapy period. Treatment with bevacizumab repeats every 3 weeks for 30 weeks in the absence of disease progression or unacceptable toxicity. Patients who are estrogen receptor- or progesterone receptor-positive (≥ 10% by IHC) receive the following concurrent hormonal therapy beginning in week 7:
* Premenopausal patients: Patients receive tamoxifen citrate for 5 years.
* Postmenopausal patients: Patients receive aromatase-inhibitor therapy (or tamoxifen citrate if unable to tolerate anti-aromatase therapy) for 5 years.
* Perimenopausal patients: Patients receive tamoxifen citrate for 2-3 years and aromatase-inhibitor therapy for 2-3 years OR tamoxifen citrate for 5 years followed by aromatase-inhibitor therapy for 2-3 years (if follicle-stimulating hormone \> 30 IU/L and/or estradiol \< 30 ng/L).
After completion of study treatment, patients are followed for at least 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description (FEC / Docetaxel) + Bevacizumab epirubicin hydrochloride Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year (FEC / Docetaxel) + Bevacizumab bevacizumab Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year (FEC / Docetaxel) + Bevacizumab fluorouracil Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year (FEC / Docetaxel) + Bevacizumab cyclophosphamide Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year (FEC / Docetaxel) + Bevacizumab docetaxel Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
- Primary Outcome Measures
Name Time Method Complete histologic response rate Post surgery
- Secondary Outcome Measures
Name Time Method Genomic and proteomic analyses and correlation with histologic response Post surgery Progression-free survival 3 and 5 years Overall survival 3 and 5 years Predictive factors of response to bevacizumab 3 and 5 years Circulating peripheral cells (circulating endothelial and tumor cells): correlation of initial rate and association with histological response after surgery Post-surgery Toxicity as assessed by CTCAE v3.0 3 and 5 years
Trial Locations
- Locations (28)
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Bergonie
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
CMC Les Ormeaux
🇫🇷Le Havre, France
Centre Oscar Lambret
🇫🇷Lille, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Hospitalier General Andre Boulloche
🇫🇷Montbeliard, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Curie Hopital
🇫🇷Paris, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Leon Berard
🇫🇷Lyon, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Henri Becquerel
🇫🇷Rouen, France
CRLCC Nantes - Atlantique
🇫🇷Saint-Herblain, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut Claudius Regaud
🇫🇷Toulouse, France