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A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

NCT ID: NCT00559754

Last Updated: 2014-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-09-30

Brief Summary

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This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on study treatment is 3-12 months, 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 on day 1 of each 3 week cycle

Docetaxel

Intervention Type DRUG

75mg/m2 iv on day 1 of each 3 week cycle

Standard chemotherapy

Intervention Type DRUG

As prescribed

Interventions

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bevacizumab [Avastin]

15mg/kg iv on day 1 of each 3 week cycle

Intervention Type DRUG

Docetaxel

75mg/m2 iv on day 1 of each 3 week cycle

Intervention Type DRUG

Standard chemotherapy

As prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female patients, \>=18 years of age;
* primary HER2-negative operable breast cancer;
* tumor \>2cm in size;
* ECOG performance status 0-1.

Exclusion Criteria

* previous treatment for breast cancer;
* metastatic disease;
* current or recent (within 10 days of first dose of Avastin) use of aspirin (\>325mg/day) or full-dose anticoagulants for therapeutic purposes;
* clinically significant cardiovascular disease.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

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

Locations

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Sabadell, Barcelona, Barcelona, Spain

Site Status

Córdoba, Cordoba, Spain

Site Status

Jaén, Jaen, Spain

Site Status

Lleida, Lerida, Spain

Site Status

Málaga, Malaga, Spain

Site Status

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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ML20382

Identifier Type: -

Identifier Source: org_study_id