Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients (Beverly1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00820547|
Recruitment Status : Active, not recruiting
First Posted : January 12, 2009
Last Update Posted : August 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: bevacizumab Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||March 2018|
Experimental: (FEC / Docetaxel) + Bevacizumab
Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year
During neoadjuvant phase: 15 mg/kg, d1 q3w, 8 cycles During adjuvant phase:15 mg/kg, d1 q3w, 10 cyclesDrug: cyclophosphamide
Neoadjuvant: 500 mg/m2 d1 q3w, 4 cyclesDrug: docetaxel
Neoadjuvant: 100 mg/m2 q3w, 4 cyclesDrug: epirubicin hydrochloride
Neoadjuvant: 100 mg/m2, d1 q3w, 4 cyclesDrug: fluorouracil
Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles
- Complete histologic response rate [ Time Frame: Post surgery ]
- Progression-free survival [ Time Frame: 3 and 5 years ]
- Overall survival [ Time Frame: 3 and 5 years ]
- Toxicity as assessed by CTCAE v3.0 [ Time Frame: 3 and 5 years ]
- Predictive factors of response to bevacizumab [ Time Frame: 3 and 5 years ]
- Circulating peripheral cells (circulating endothelial and tumor cells): correlation of initial rate and association with histological response after surgery [ Time Frame: Post-surgery ]
- Genomic and proteomic analyses and correlation with histologic response [ Time Frame: Post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820547
|Centre Paul Papin|
|Angers, France, 49036|
|Institut Sainte Catherine|
|Avignon, France, 84000|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Bordeaux, France, 33076|
|Polyclinique Bordeaux Nord Aquitaine|
|Bordeaux, France, 33300|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|CMC Les Ormeaux|
|Le Havre, France, 76600|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Hospitalier General Andre Boulloche|
|Montbeliard, France, 25209|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Catherine de Sienne|
|Nantes, France, 02|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Institut Curie Hopital|
|Paris, France, 75248|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Hopitaux Universitaire de Strasbourg|
|Strasbourg, France, 67091|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Principal Investigator:||Patrice Viens, MD||Institut Paoli-Calmettes|