Study Stopped
The number of inclusion was reached normally
Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer
1 other identifier
interventional
64
1 country
17
Brief Summary
Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 17, 2016
March 1, 2016
1.9 years
February 16, 2010
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
objective response rate
36 months for recrutment and 30 months for follow up
Study Arms (1)
Association bevacizumab paclitaxel capecitabine breast cancer
EXPERIMENTAL* bevacizumab 10 mg/kg in IV, D1 and D15 * paclitaxel 80mg/m2 in IV, D1 to D8 and D15 * capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3
Interventions
800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 \& 3
Eligibility Criteria
You may qualify if:
- Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
- Measurable disease
- Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry
You may not qualify if:
- Prior chemotherapy for metastatic disease
- HER2 positive and/or hormonal receptor positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Centre Paul Papin
Angers, France
Clinique Tivoli
Bordeaux, France
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Centre Hospitalier Intercommunal
Fréjus, France
Clinique des 4 Pavillons
Lormont, France
Hôpital Privé Clairval
Marseille, France
Centre Azuréen de Cancérologie
Mougins, France
Centre Alexis Vautrin
Nancy, France
Centre Antoine Lacassagne
Nice, France
Centre Hospitalier Régional
Orléans, France
Institut Jean Godinot
Reims, France
Hôpitaux Drôme Nord - Site de Romans-sur-Isère
Romans-sur-Isère, France
Centre Henri Becquerel
Rouen, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
Clinique de l'Union
St.-Jean, France
Centre Paul Strauss
Strasbourg, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2012
Study Completion
June 1, 2014
Last Updated
March 17, 2016
Record last verified: 2016-03