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A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)

NCT ID: NCT01156961

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WITHDRAWN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

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

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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Single Arm

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks

paclitaxel

Intervention Type DRUG

90 mg/m2 iv days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 iv day 1 of each 21-day cycle

Interventions

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bevacizumab [Avastin]

10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks

Intervention Type DRUG

paclitaxel

90 mg/m2 iv days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 iv day 1 of each 21-day cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Locally recurrent or metastatic Her2-negative breast cancer
* Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of \>/=12 months is required
* Adequate haematological, renal and liver function

Exclusion Criteria

* Previous chemotherapy for locally recurrent or metastatic disease
* Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of \</= 30% of marrow-bearing bone)
* CNS metastases
* Pre-existing peripheral neuropathy
* 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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Russia

Other Identifiers

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ML25081

Identifier Type: -

Identifier Source: org_study_id