Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

NCT ID: NCT01069796

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Triple Negative Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Association bevacizumab paclitaxel capecitabine breast cancer

* 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

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

80 mg/m² weekly

Bevacizumab

Intervention Type DRUG

10 mg/kg d1 d15

Capecitabine

Intervention Type DRUG

800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 \& 3

Interventions

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Paclitaxel

80 mg/m² weekly

Intervention Type DRUG

Bevacizumab

10 mg/kg d1 d15

Intervention Type DRUG

Capecitabine

800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 \& 3

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Paul Papin

Angers, , France

Site Status

Clinique Tivoli

Bordeaux, , France

Site Status

Centre Hospitalier William Morey

Chalon-sur-Saône, , France

Site Status

Centre Hospitalier Intercommunal

Fréjus, , France

Site Status

Clinique des 4 Pavillons

Lormont, , France

Site Status

Hôpital Privé Clairval

Marseille, , France

Site Status

Centre Azuréen de Cancérologie

Mougins, , France

Site Status

Centre Alexis Vautrin

Nancy, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Centre Hospitalier Régional

Orléans, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Hôpitaux Drôme Nord - Site de Romans-sur-Isère

Romans-sur-Isère, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Site Status

Clinique de l'Union

St.-Jean, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Centre Hospitalier Bretagne Atlantique

Vannes, , France

Site Status

Countries

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France

Other Identifiers

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A-Taxel (GINECO BR108)

Identifier Type: -

Identifier Source: org_study_id

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