A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

NCT ID: NCT00717405

Last Updated: 2016-08-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Standard chemotherapy

Intervention Type DRUG

As prescribed

bevacizumab [Avastin]

Intervention Type DRUG

15mg/kg iv 3 weekly in cycles 1-8

trastuzumab [Herceptin]

Intervention Type DRUG

8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard chemotherapy

As prescribed

Intervention Type DRUG

bevacizumab [Avastin]

15mg/kg iv 3 weekly in cycles 1-8

Intervention Type DRUG

trastuzumab [Herceptin]

8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult females, \>=18 years of age;
* inflammatory breast cancer;
* HER2-positive tumors;
* performance status 0-2.

Exclusion Criteria

* metastases;
* previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
* clinically significant cardiovascular disease, or history of thrombotic disorders.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Besançon, , France

Site Status

Bordeaux, , France

Site Status

Brest, , France

Site Status

Caen, , France

Site Status

Clermont-Ferrand, , France

Site Status

Dijon, , France

Site Status

La Tronche, , France

Site Status

Lille, , France

Site Status

Lyon, , France

Site Status

Marseille, , France

Site Status

Montpellier, , France

Site Status

Nantes, , France

Site Status

Nice, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Reims, , France

Site Status

Rennes, , France

Site Status

Rouen, , France

Site Status

Saint-Brieuc, , France

Site Status

Saint-Cloud, , France

Site Status

Saint-Herblain, , France

Site Status

Saint-Priest-en-Jarez, , France

Site Status

Strasbourg, , France

Site Status

Strasbourg, , France

Site Status

Toulouse, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Villejuif, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.

Reference Type DERIVED
PMID: 22377126 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-000783-16

Identifier Type: -

Identifier Source: secondary_id

ML21531

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.