NCT00964704

Brief Summary

This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2 breast-cancer

Status
withdrawn

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

August 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.4 years

First QC Date

August 21, 2009

Last Update Submit

November 1, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival on second-line treatment

    event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter

Secondary Outcomes (2)

  • Safety and tolerability: AEs, laboratory parameters, LVEF

    throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks

  • Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival

    event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter

Study Arms (1)

Single Arm

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

Interventions

bevacizumab [Avastin]DRUG

15mg/kg iv every 3 weeks

Single Arm
capecitabine [Xeloda]DRUG

added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle

Single Arm
docetaxelDRUG

background therapy at time of disease progression, 100mg/m2 iv every 3 weeks

Single Arm
trastuzumab [Herceptin]DRUG

8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Single Arm

Eligibility Criteria

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

You may qualify if:

  • male or female patients, age \>/=18 years
  • locally recurrent or metastatic HER2-positive breast cancer
  • disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
  • LVEF \>/=55% at baseline

You may not qualify if:

  • prior treatment with bevacizumab or capecitabine
  • anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
  • chronic daily treatment with corticosteroids (\>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (\>325mg/day), or clopidogrel (\>75mg/day)
  • clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
  • evidence of spinal cord compression or CNS metastasis
  • history of other malignancy, unless disease-free for \>/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BevacizumabCapecitabineDocetaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR
0

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

August 21, 2009

First Posted

August 25, 2009

Study Start

March 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11