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)

Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01156961

Enrollment

Registered

2010-07-05

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

DRUGbevacizumab [Avastin]

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

DRUGpaclitaxel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety profile: Adverse events	approximately 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026