NCT00717405

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2008

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 6, 2016

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

July 16, 2008

Results QC Date

December 1, 2015

Last Update Submit

July 5, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification

    PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than \[\>\] 50 percent \[%\] therapeutic effect but less than \[\<\] T-A), T-C (\<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.

    From baseline through Week 25 (Up to 6 months)

Secondary Outcomes (13)

  • Percentage of Participants With a PCR According to the Chevallier Classification

    From baseline through Week 25 (Up to 6 months)

  • Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit

    Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)

  • Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit

    Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)

  • Number of Participants Who Underwent Mastectomy

    Anytime between Week 26 and Week 29

  • Percentage of Participants With Macroscopically Visible Tumor

    Anytime between Week 26 and Week 29

  • +8 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: Standard chemotherapyDrug: bevacizumab [Avastin]Drug: trastuzumab [Herceptin]

Interventions

Standard chemotherapyDRUG

As prescribed

1
bevacizumab [Avastin]DRUG

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

1
trastuzumab [Herceptin]DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Besançon, 25030, France

Location

Unknown Facility

Bordeaux, 33000, France

Location

Unknown Facility

Brest, 29609, France

Location

Unknown Facility

Caen, 14076, France

Location

Unknown Facility

Clermont-Ferrand, 63011, France

Location

Unknown Facility

Dijon, 21079, France

Location

Unknown Facility

La Tronche, 38700, France

Location

Unknown Facility

Lille, 59020, France

Location

Unknown Facility

Lyon, 69373, France

Location

Unknown Facility

Marseille, 13273, France

Location

Unknown Facility

Montpellier, 34298, France

Location

Unknown Facility

Nantes, 44202, France

Location

Unknown Facility

Nice, 06189, France

Location

Unknown Facility

Paris, 75231, France

Location

Unknown Facility

Paris, 75475, France

Location

Unknown Facility

Paris, 75970, France

Location

Unknown Facility

Reims, 51056, France

Location

Unknown Facility

Rennes, 35042, France

Location

Unknown Facility

Rouen, 76038, France

Location

Unknown Facility

Saint-Brieuc, 22015, France

Location

Unknown Facility

Saint-Cloud, 92210, France

Location

Unknown Facility

Saint-Herblain, 44805, France

Location

Unknown Facility

Saint-Priest-en-Jarez, 42271, France

Location

Unknown Facility

Strasbourg, 67065, France

Location

Unknown Facility

Strasbourg, 67098, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Related Publications (1)

  • 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.

    PMID: 22377126DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2010

Study Completion

October 1, 2014

Last Updated

August 2, 2016

Results First Posted

January 6, 2016

Record last verified: 2016-07

Locations

FR(28)