NCT02005549

Brief Summary

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 6, 2014

Completed
Last Updated

July 14, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

December 4, 2013

Results QC Date

May 7, 2014

Last Update Submit

June 30, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Pathological Complete Response (pCR)

    pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.

    Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])

Secondary Outcomes (2)

  • Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)

    Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])

  • Percentage of Participants Undergoing Breast-Conserving Surgery

    20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])

Study Arms (1)

Neoadjuvant Therapy

EXPERIMENTAL
Drug: bevacizumab [Avastin]Drug: docetaxelDrug: capecitabine [Xeloda]

Interventions

bevacizumab [Avastin]DRUG

15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles

Neoadjuvant Therapy
docetaxelDRUG

75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles

Neoadjuvant Therapy
capecitabine [Xeloda]DRUG

950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks

Neoadjuvant Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients, 18-70years of age;
  • histologically-proven invasive breast cancer;
  • no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
  • no distant disease/secondary cancer.

You may not qualify if:

  • pregnant or lactating women;
  • pre-operative local treatment for breast cancer;
  • prior or concurrent systemic antitumor therapy;
  • clinically significant cardiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabDocetaxelCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Results Point of Contact

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 9, 2013

Study Start

February 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 14, 2014

Results First Posted

June 6, 2014

Record last verified: 2014-05

Locations

AU(1)