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WithdrawnNCT01156961Updated Nov 2, 2016

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)

A Phase 4 interventional study of bevacizumab [Avastin] and paclitaxel in Breast Cancer, sponsored by Hoffmann-La Roche. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Absence of patient's recruitment in the study due to administrative reasons
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

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Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Single Arm

    Drug: bevacizumab [Avastin] · Drug: paclitaxel

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

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What researchers measure

Primary outcomes

  1. Safety profile: Adverse events

    Time frame: approximately 2 years

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01156961
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 5, 2010
Start date
Oct 2010
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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