Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01663727
First received: August 9, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This is a Phase III, randomized, double-blind, placebo-controlled multicenter st udy to evaluate the efficacy and safety of bevacizumab administered in combinati on with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of tw

o treatment arms: bevacizumab or placebo. All patients will be given an intraven ous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cyc le. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Day s 1 and 15 of each 28-day cycle. Patients will be treated until disease progress ion, unacceptable toxicity or death from any cause occurs.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Bevacizumab [Avastin]
Drug: Paclitaxel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival based on investigator tumor assessment in the intent-to-treat patient population [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Progression-free survival based on investigator tumor assessment in intent-to-treat patients with high plasma vascular endothelial growth factor A (VEGF-A) levels [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of interaction of treatment effect with VEGF-A levels for progression-free survival in the intent-to-treat patient population [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At approximately 52 months and at approximately 78 months ] [ Designated as safety issue: No ]
  • Objective response rate for patients with measurable disease at baseline, defined as complete or partial response as assessed by investigator according to RECIST v1.1 [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease at baseline, as determined by investigator review of tumor assessments using RECIST v1.1 [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • One-year survival rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Enrollment: 479
Study Start Date: August 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Paclitaxel + Bevacizumab [Avastin]
Drug: Bevacizumab [Avastin]
Intravenous repeating dose
Drug: Paclitaxel
Intravenous repeating dose
Experimental: B
Paclitaxel + Placebo
Drug: Paclitaxel
Intravenous repeating dose
Drug: Placebo
Intravenous repeating dose

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
  • ECOG performance status of 0 or 1
  • For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
  • For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

  • HER2-positive status
  • Prior chemotherapy for locally recurrent or metastatic disease
  • Prior hormonal therapy < 2 weeks prior to randomization
  • Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
  • Investigational therapy within 28 days of randomization

General Medical Exclusions:

  • Life expectancy of < 12 weeks
  • Inadequate organ function
  • Uncontrolled serious medical or psychiatric illness
  • Active infection requiring intravenous (IV) antibiotics at screening
  • Pregnancy or lactation
  • History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
  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: NCT01663727

  Show 177 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01663727     History of Changes
Other Study ID Numbers: GO25632, 2011-005335-97
Study First Received: August 9, 2012
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014