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PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

NCT ID: NCT00774241

Last Updated: 2016-11-02

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-11-30

Brief Summary

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This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

15mg/kg iv every 3 weeks

docetaxel

Intervention Type DRUG

75mg/m2 every 3 weeks for 18 weeks

Interventions

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bevacizumab [Avastin]

15mg/kg iv every 3 weeks

Intervention Type DRUG

docetaxel

75mg/m2 every 3 weeks for 18 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male and female patients, \>=18 years of age;
* stage IV, HER2 negative metastatic breast cancer;
* candidate for taxane-based therapy;
* ECOG performance status 0-2.

Exclusion Criteria

* prior chemotherapy for metastatic breast cancer;
* concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
* suspicion of CNS metastasis;
* clinically significant cardiovascular disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

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Mexico

Other Identifiers

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ML21343

Identifier Type: -

Identifier Source: org_study_id