Back to resultsBevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
Primary Purpose
Triple Negative Metastatic Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Paclitaxel
Bevacizumab
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Triple Negative Metastatic Breast Cancer focused on measuring triple negative, metastatic, breast cancer, First line chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior chemotherapy for metastatic disease
- HER2 positive and/or hormonal receptor positive
Sites / Locations
- Centre Paul Papin
- Clinique Tivoli
- Centre Hospitalier William Morey
- Centre Hospitalier Intercommunal
- Clinique des 4 Pavillons
- Hôpital Privé Clairval
- Centre Azuréen de Cancérologie
- Centre Alexis Vautrin
- Centre Antoine Lacassagne
- Centre Hospitalier Régional
- Institut Jean Godinot
- Hôpitaux Drôme Nord - Site de Romans-sur-Isère
- Centre Henri Becquerel
- Clinique Armoricaine de Radiologie
- Clinique de l'Union
- Centre Paul Strauss
- Centre Hospitalier Bretagne Atlantique
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Association bevacizumab paclitaxel capecitabine breast cancer
Arm Description
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
Outcomes
Primary Outcome Measures
objective response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01069796
Brief Title
Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
The number of inclusion was reached normally
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCAGY/ GINECO GROUP
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Metastatic Breast Cancer
Keywords
triple negative, metastatic, breast cancer, First line chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Association bevacizumab paclitaxel capecitabine breast cancer
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80 mg/m² weekly
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
10 mg/kg d1 d15
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
36 months for recrutment and 30 months for follow up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Prior chemotherapy for metastatic disease
HER2 positive and/or hormonal receptor positive
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon sur Saône
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Fréjus
Country
France
Facility Name
Clinique des 4 Pavillons
City
Lormont
Country
France
Facility Name
Hôpital Privé Clairval
City
Marseille
Country
France
Facility Name
Centre Azuréen de Cancérologie
City
Mougins
Country
France
Facility Name
Centre Alexis Vautrin
City
Nancy
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Centre Hospitalier Régional
City
Orléans
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Hôpitaux Drôme Nord - Site de Romans-sur-Isère
City
Romans sur Isère
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Clinique Armoricaine de Radiologie
City
Saint Brieuc
Country
France
Facility Name
Clinique de l'Union
City
St Jean
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Centre Hospitalier Bretagne Atlantique
City
Vannes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
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