Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
ARCAGY/ GINECO GROUP
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT01069796
First received: February 16, 2010
Last updated: April 19, 2012
Last verified: April 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Triple Negative Metastatic Breast Cancer |
Drug: Paclitaxel Drug: Bevacizumab Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by ARCAGY/ GINECO GROUP:
Primary Outcome Measures:
- objective response rate [ Time Frame: 36 months for recrutment and 30 months for follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 62 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2015 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Paclitaxel
80 mg/m² weekly
Drug: Bevacizumab
10 mg/kg d1 d15
Drug: Capecitabine
800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069796
Locations
| France | |
| 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 | |
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
More Information
No publications provided
| Responsible Party: | ARCAGY/ GINECO GROUP |
| ClinicalTrials.gov Identifier: | NCT01069796 History of Changes |
| Other Study ID Numbers: | A-Taxel (GINECO BR108) |
| Study First Received: | February 16, 2010 |
| Last Updated: | April 19, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: CPP |
Keywords provided by ARCAGY/ GINECO GROUP:
|
triple negative metastatic breast cancer First line chemotherapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Capecitabine Bevacizumab Fluorouracil Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013