A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00448591
First received: March 16, 2007
Last updated: May 21, 2015
Last verified: May 2015
  Purpose

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Taxane-based chemotherapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs) [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion ] [ Designated as safety issue: Yes ]
    Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.


Secondary Outcome Measures:
  • Percentage of Participants With Disease Progression [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ] [ Designated as safety issue: No ]
    Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

  • Time to Progression (TTP) [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ] [ Designated as safety issue: No ]
    TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.

  • Percentage of Participants With Recorded Death [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months ] [ Designated as safety issue: No ]
    Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.

  • Percentage of Participants by Best Overall Response to Treatment [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ] [ Designated as safety issue: No ]
    Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.


Enrollment: 2296
Study Start Date: September 2006
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
Drug: Taxane-based chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients, >=18 years of age;
  • HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
  • candidates for chemotherapy.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • concomitant hormonal therapy for metastatic or locally recurrent disease;
  • concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
  • previous radiotherapy for treatment of metastatic disease;
  • evidence of CNS metastases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448591

  Show 457 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448591     History of Changes
Other Study ID Numbers: MO19391
Study First Received: March 16, 2007
Results First Received: December 22, 2014
Last Updated: May 21, 2015
Health Authority: Australia: Joint Human Research Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Taxane
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015