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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717405
First received: July 16, 2008
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Standard chemotherapy
Drug: trastuzumab [Herceptin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of pathological complete response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival; recurrence free interval; overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs; cardiac safety [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2008
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv 3 weekly in cycles 1-8
Drug: Standard chemotherapy
As prescribed
Drug: trastuzumab [Herceptin]
8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.

  Eligibility

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

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.
  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: NCT00717405

Locations
France
Besancon, France, 25030
Bordeaux, France, 33000
Brest, France, 29609
Caen, France, 14076
Clermont Ferrand, France, 63011
Dijon, France, 21079
La Tronche, France, 38700
Lille, France, 59020
Lyon, France, 69373
Marseille, France, 13273
Montpellier, France, 34298
Nantes, France, 44202
Nice, France, 06189
Paris, France, 75231
Paris, France, 75970
Paris, France, 75475
Reims CEDEX, France, 51056
Rennes, France, 35042
Rouen, France, 76038
Saint Brieuc, France, 22015
Saint Herblain, France, 44805
St Cloud, France, 92210
St Priest En Jarez, France, 42271
Strasbourg, France, 67098
Strasbourg, France, 67065
Toulouse, France, 31059
Vandoeuvre Les Nancy, France, 54511
Villejuif, France, 94805
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: NCT00717405     History of Changes
Other Study ID Numbers: ML21531, 2008-000783-16
Study First Received: July 16, 2008
Last Updated: November 3, 2014
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Trastuzumab
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 November 25, 2014