NCT00454805

Brief Summary

The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

Geographic Reach
3 countries

16 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

Study Start

First participant enrolled

March 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

November 28, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

March 29, 2007

Results QC Date

April 25, 2012

Last Update Submit

July 6, 2016

Conditions

Advanced Breast Cancer

Keywords

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

    RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

Secondary Outcomes (4)

  • Objective Response Rate

    RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

  • Duration of Response

    Every 8 weeks until progression or discontinuation

  • Clinical Benefit Rate

    Every 8 weeks until progression or discontinuation

  • Duration of Clinical Benefit

    Every 8 weeks until progression or discontinuation

Study Arms (2)

2

ACTIVE COMPARATOR

Fulvestrant Monotherapy

Drug: Fulvestrant

3

EXPERIMENTAL

AZD2171 + Fulvestrant

Drug: AZD2171Drug: Fulvestrant

Interventions

AZD2171DRUG

Oral tablet

Also known as: Recentin
3
FulvestrantDRUG

intramuscular injection

Also known as: Faslodex, ZD9238
23

Eligibility Criteria

Age18 Years - 130 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
  • One or more evaluable lesions

You may not qualify if:

  • Prior hormonal therapy with fulvestrant
  • More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer
  • Prior biologic therapy for ABC including Anti-VEGF agents
  • Radiation therapy within 4 weeks prior to provision of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Site

Burbank, California, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Palm Springs, California, United States

Location

Research Site

Boca Raton, Florida, United States

Location

Research Site

Honolulu, Hawaii, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Fitzroy, Australia

Location

Research Site

Parkville, Australia

Location

Research Site

Perth, Australia

Location

Research Site

Waratah, Australia

Location

Research Site

Belo Horizonte, Brazil

Location

Research Site

Curitiba, Brazil

Location

Research Site

Fortaleza, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Santro Andre, Brazil

Location

Research Site

São Paulo, Brazil

Location

Related Publications (1)

  • Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26.

    PMID: 23801303DERIVED

Related Links

MeSH Terms

Interventions

cediranibFulvestrant

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Bijoyesh Mookerjee, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2007

First Posted

April 2, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

April 1, 2016

Last Updated

August 3, 2016

Results First Posted

November 28, 2012

Record last verified: 2016-07

Locations

US(6)AU(4)BR(6)